This is an exciting opportunity for a highly experienced, independent clinical biostatistician to advance adoption of Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials. You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio.

The ideal candidate brings deep statistical expertise, strong scientific communication skills, and a proven track record of applying innovative methodologies to oncology clinical trial design in a fast-paced, cross-functional environment.

PRIMARY RESPONSIBILITIES: 

• Study Design and Statistical Strategy: Lead the statistical design and analytical planning for oncology clinical utility studies. Provide technical expertise in complex study design methodologies and data analyses. Propose and justify efficient study designs tailored to complex oncology use cases.

• Cross-Functional Collaboration: Serve as study statistician for multiple studies. Collaborate with clinical, medical, and translational partners to influence study planning, development, and execution. Identify risks, proactively communicate concerns, and champion solutions to interdisciplinary teams and executive leaders.

• Documentation and Reporting: Author and review high-quality statistical deliverables, including statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders. 

• Innovation and Improvement: Recommend and apply novel statistical approaches where appropriate. Mentor early career statisticians and support continuous improvement of departmental processes, tools, and templates to enhance team efficiency and analytical rigor.  Collaborate on manuscripts for publications.

QUALIFICATIONS: 

• Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).

• 4+ years of experience in clinical trial biostatistics.

• Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology.

• Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation.

• Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM).

• Proficient in R.

KNOWLEDGE, SKILLS, AND ABILITIES: 

• Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges.

• Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation.

• Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds.

• Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences.

Preferred qualifications: 

• Working-knowledge of NGS-based diagnostics and ctDNA/MRD.
• Experience with non-inferiority studies.

This is an exciting opportunity for a highly experienced, independent clinical biostatistician to advance adoption of Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials. You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio.

The ideal candidate brings deep statistical expertise, strong scientific communication skills, and a proven track record of applying innovative methodologies to oncology clinical trial design in a fast-paced, cross-functional environment.

PRIMARY RESPONSIBILITIES: 

• Study Design and Statistical Strategy: Lead the statistical design and analytical planning for oncology clinical utility studies. Provide technical expertise in complex study design methodologies and data analyses. Propose and justify efficient study designs tailored to complex oncology use cases.

• Cross-Functional Collaboration: Serve as study statistician for multiple studies. Collaborate with clinical, medical, and translational partners to influence study planning, development, and execution. Identify risks, proactively communicate concerns, and champion solutions to interdisciplinary teams and executive leaders.

• Documentation and Reporting: Author and review high-quality statistical deliverables, including statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders. 

• Innovation and Improvement: Recommend and apply novel statistical approaches where appropriate. Mentor early career statisticians and support continuous improvement of departmental processes, tools, and templates to enhance team efficiency and analytical rigor.  Collaborate on manuscripts for publications.

QUALIFICATIONS: 

• Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).

• 4+ years of experience in clinical trial biostatistics.

• Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology.

• Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation.

• Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM).

• Proficient in R.

KNOWLEDGE, SKILLS, AND ABILITIES: 

• Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges.

• Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation.

• Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds.

• Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences.

Preferred qualifications: 

• Working-knowledge of NGS-based diagnostics and ctDNA/MRD.
• Experience with non-inferiority studies.

The Opportunity:

Playing a critical role as a filing and program lead statistician for clinical Late-Stage program(s) and the subject matter expert (SME) in Biostatistics within Quantitative Sciences function, this position is to serve as a program level lead statistician and provide statistical leadership and support for clinical development strategy and programs through product life cycle.

• Lead strategic, statistical thinking and contributions to clinical development plans.

• Represent Biostatistics function on cross-function teams at program level and serve as a lead statistician for oncology studies.

• Collaborate with various functions on study design and planning, protocol development, statistical analysis plan and analysis specifications.

• Provide statistical support for study protocol development, analysis plan and specification through direct involvement and/or providing guidance to junior staff.

• Plan and prepare independent data monitoring committee (DMC), coordinate with independent statistical data analysis center for DMC and study team for periodic DMC reviews.

• Collaborate with data management and clinical operations over the course of clinical studies to provide statistical input to study conducts and database development as well as data collection and cleaning activities.

• Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.

• Provide statistical input and leadership to the development of global health authority documents, regulatory interaction and response to health authority submissions.

• Provide statistical support for clinical publications, assist in data interpretation to ensure consistency and accuracy in data presentation.

• Drive and lead department initiatives, best practices, and guidelines.

• Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, minimum 10 years (for Ph.D.) and 14 years (for M.S.) of experience in biotech/pharma industry as a statistician. Level will be determined based on the relevance of experience.

• Extensive experience in design and conduct of phase 3 oncology trials.

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Experience with lead role in NDA/BLA filing desirable.

#LI-Hybrid  #LI-SH1

About the Company

General Matter is enriching uranium in America. 

Our goal is to design, build, and operate the world’s lowest-cost enrichment services in the United States.  

Our mission is to restore America’s ability to produce nuclear fuel—fuel that will power AI, advanced manufacturing, critical industries, and the next generation of nuclear reactors. 

Ultimately, our work will help power national ambitions and enable a high-energy society. 

We were incubated by Founders Fund, like Anduril and Palantir before us, and are backed by top-tier investors. Our lean, world-class team of engineers and operators is applying a first-principles approach to solving the problem of nuclear fuel production.  

We are a mission-driven company with a culture of urgency, accountability, and transparency. 

Help us build a high-energy society by making the cleanest, safest form of baseload energy the most affordable. 

About This Role

As a Statistician, you will support General Matter's Nuclear Material Control & Accountability program. This program is key to ensuring the safe, secure, and compliant management of nuclear material. This role is ideal for someone with strong math skills who can apply them to real-world measurements and are keenly detail oriented to ensure accurate documentation and reporting for compliance. You will work alongside engineers to ensure accurate tracking of nuclear materials in compliance with NRC regulations. 

Responsibilities

• Perform basic statistical calculations to support inventory checks and material balances.
• Track and verify measurement data, including weights, volumes, and assay results.
• Calculate averages, error margins, and simple uncertainty estimates for measurements.
• Help design and check forms, spreadsheets, and databases used for MC&A reporting.
• Support periodic physical inventories and reconcile records with actual counts.
• Assist in preparing compliance reports and internal audits.
• Work with engineers and safeguards staff to learn applied MC&A concepts.

Basic Qualifications

• Bachelor’s degree in Math, Statistics,, Physics, or a related field. 
• Proficiency in advanced math fundamentals, including algebra, probability, and descriptive statistics (means, variance, standard deviation, error propagation).
• Proficiency in Excel.
• Excellent attention to detail and problem solving abilities. 

Preferred Skills and Experience

• Evidence of exceptional ability (prior projects, portfolio of work, completed products, etc).
• Experience in a fast-paced engineering environment or a highly technical role requiring a resourceful, entrepreneurial approach to complete tasks within tight timeframes or budget constraints.
• Strong verbal and written communication skills, with the ability to convey math concepts clearly to diverse audiences.
• Ability to work collaboratively in a team-oriented environment.
• Willingness and ability to quickly learn regulatory requirements.
• Familiarity with physics or chemistry concepts.
• Interest in learning about nuclear safeguards and regulatory compliance. 

Additional Requirements

• Ability to work extended hours and weekends as necessary.

Equal Opportunity Employer

General Matter is an Equal Opportunity Employer; employment with General Matter is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, gender, national origin/ethnicity, veteran status, disability status, age, sexual orientation, gender identity, marital status, mental or physical disability or any other legally protected status.

Compensation and Benefits

The base salary range for this role is $75,000-$120,000 annually. 

Compensation bands are determined by role, level, location, and alignment with market data. Individual level and base pay is determined on a case-by-case basis and may vary based on job-related skills, education, experience, technical capabilities and internal equity. Please note that the stated salary range is an estimate and may be adjusted based on market conditions, business needs, or other factors. In addition to base salary, for full-time hires, you may also be eligible for long-term incentives, in the form of stock options, and access to medical, vision & dental coverage as well as access to a 401(k) retirement plan.

How you'll help us achieve it

We’re looking for a Training Administrator who pays close attention to detail, can multitask, and works well under pressure. As a Training Administrator, your goal will be to ensure that most agents, distributors, and staff participate in our training sessions and that they run. You should be a reliable problem-solver with strong project management skills. You'll be responsible for communicating with agents and distributors, assisting trainers with the reservation of training rooms, dispatching training goodies, calling agents, organizing training agendas, and completing reports. 

In this role, you'll; 

• Call and invite participants to the in-region training organized by the trainers.
• Maintain training records (e.g., trainee lists, schedules, attendance sheets).
• Design a dashboard for key metrics, monitor data, and analyze.
• Book training rooms and ensure they’re properly set up.
• Prepare and disseminate material (e.g., instructional notes, feedback forms). 
• Act as a point of contact for participants.
• Handle and respond to daily training requests. 
• Develop creative and innovative approaches to present training programs.
• Handle accounts receivable and ensure invoices are paid.
• Submit reports on training activities and results on a daily and weekly basis.
• Write daily and weekly notes.

Key details

• Location: You'll work from our office in Ouagadougou, with frequent travels to the upcountry.
• Work authorization in Burkina is required. 
• This is a 6-month fixed-term contract. 
• Our salaries are competitive and calculated using a transparent formula. 
• We offer generous health insurance for yourself and your dependents.
• We support working parents - we offer (26 weeks for mothers and 4 weeks for fathers) and subsidized child care when you return to work.
• We help you live your fullest life now- we subsidize gym memberships and fitness classes.
• Airtime reimbursement.
• Free food and a beautiful office space.

Requirements

• Bachelor’s degree in Statistics, Mathematics, IT, or a related field.
• Proven experience as a Training Administrator, Statistician, Data Analyst, or a similar role.
• Strong proficiency in Google Sheets and/or Excel. 
• Excellent organizational and multitasking ability.
• Outstanding communication skills.
• Strong attention to detail.

You might be a good fit if you

• Are excessively detail-oriented and seek to achieve excellence in everything you do.
• Are patient and empathetic.
• Are a self-starter and proactive about achieving ambitious targets.
• Are excited to conduct online training and assessments.
• Enjoy organizing large events - you'll be the point of contact to both suppliers and the team.
• Are able to adapt quickly to different environments.
• Willing to go the distance to get something done.
• Are rigorous, autonomous, methodical, and with an eye for detail.
• Are intellectually curious, creative in the way you go about tackling problems, and embrace failure as a means to spark innovation and growth.
• Are comfortable defaulting to over-communication and overreaching when it comes to coordination.
• Adjust quickly to changing priorities and conditions.
• Have experience in project management.  

The Data Science & Analytics organization's mission is to increase our speed, frequency and acumen of making decisions at scale by instilling a data-influenced approach to building products. We cover a wide area of the data spectrum including analytical data engineering, product analytics, experimentation, causal inference, statistical modeling and machine learning. Aligned and partnering with product groups, we use this vast tool belt to discover new opportunities and unmet use cases, influence and shape the product roadmap and prioritization, build data products and measure the impact on our community of players and developers.

Roblox is used by tens of millions of people every day, across almost all devices (mobile, desktop, console, VR, etc.). Our users expect top-notch app performance: lightning-quick launches, buttery smooth animations, and rock-solid stability.  As a Data Scientist on the team, you will partner with engineers, product managers, and leaders across the company in our efforts to create the best app experience on any device for Roblox. This area is pivotal to our company’s success, directly impacting all users and being one of Roblox's highest priorities. You will define KPIs and measure the impact of key performance improvements while leveraging statistics, analytics, and experiments to influence decisions and strategies related to enhancing the performance and reliability of the Roblox app. 

You Will:

• Define and measure success metrics for App performance. Determine which performance metrics matter to end users and how app performance impacts user engagement and monetization.
• Establish an understanding of the trade-offs between different performance levers and use these insights to influence strategies, ensuring right-sized investments that optimize business growth and user experience.
• Access raw data, transform it, analyze it, and present it in a compelling and understandable way. Perform deep dives to uncover new insights and opportunities.
• Operationalize and scale metrics monitoring by building tools that enable quick slicing and dicing of data as well as root cause analysis. Collaborate with engineers to detect and investigate abnormal trends, identifying opportunities for improvement.
• Use A/B experiments and causal inference methods to evaluate the success of feature launches.
• Navigate ambiguity and work with stakeholders across various organizations, including User, Growth, Engine, and Creator teams.

You Have:

• An advanced degree or equivalent experience in Statistics, Applied Math, Physics, Engineering, Computer Science, Economics, or a related quantitative field.
• 5+ years of industry experience in a data science role, preferably with a background in app and system performance.
• Strong experience working with large datasets and proficiency in SQL, R/Python, and data visualization tools.
• Deep knowledge and practical application of statistical methods, causal inference techniques, and experimental design.
• Ability to drive an area as an individual contributor and thought leader.
• Ability to apply creative, first-principles reasoning to solve ambiguous problems.
• Strong communication skills to present analytics results and data storytelling effectively, influencing engineering teams and leaders.

You Are:

• Passionate about data. You have the curiosity and self-drive to continuously learn new techniques and tools to extract value from data. 
• Highly self-driven. You thrive with freedom and autonomy and are excited by the ambiguity that comes from exploring a new problem space. 
• A strong communicator. You understand that analysis must be presented in meaningful ways and engage in spirited discussions about the findings. You can explain technical concepts to a non-technical audience.
• A capable statistician. You understand the value of characterizing data by its distribution. Covariance, Bias, and Conditional Probability are concepts that you rely on every day.
• An expert transforming data with SQL and a scripting language such as Python or R. You’re experienced in automating efforts and crunching massive volumes of data.
• Experienced in developing models to draw insights from data. You use regression, data mining, and other statistical techniques to create new, scalable solutions to solve challenging business problems. You understand when to apply the appropriate methodology to maximize impact pragmatically.

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

OVERVIEW

The Principals Biostatisticians will work closely with clients and provide high level consulting services for statistical analysis, reporting, and statistical programming specific activities which may include development of statistics section of protocol, development of statistical analysis plan, randomization schedule, conducting statistical analyses, validating programming and reporting output, and developing statistical analysis report. Principal Biostatisticians will also work on statistical programming for development of analysis datasets, and clinical tables, listings, and graphs specific to trial reporting requirements. Principal Biostatisticians will work as needed assuring that all client work has met or exceeded client expectations.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.  

Your day to day: 

• Provide consulting of statistics activities related to clinical trials. Fulfill the responsibilities of study statistician as required
• Provide mentoring and QC of statistical programmer’s outputs; define analysis data specifications. If required, validate the statistical models used for programming
• Act as study statistician - interact with client and with clinical team including programmers, clinical data managers, clinical protocol manager, and other relevant personnel. Ensure that programmers get correct specifications and data at appropriate time
• Develop, review, and finalize the statistical analysis plan
• Validate the programming deliverables and collaborate with applicable team members to rectify any issues related to statistical reporting and analysis
• Develop randomization schedule, specifications, and guidelines
• Wherever applicable, provide input in finalization of study specific data quality control plan and ensure appropriate data analysis and reporting
• Wherever applicable, develop, validate and finalize the study specific list of table and table shells for clinical study reports and for study specific deliverables
• Ensure that all comments from the clinical team with regards to statistical report delivered for study specific deliverables are being addressed appropriately
• Analyze the data and contribute to trial progression related decisions by providing necessary input during trial specific deliverables including but not limited to blinded data reviews, and interim analyses
• Collaborate with team members for regulatory reviews, representations, and supporting data analyses including the study or compound level exploratory analyses, ad-hoc analyses, and post- hoc analyses
• Develop SAS programs to generate analysis datasets, and trial specific reporting including but not limited to tables, listings, graphs, queries, and patient profile reports
• Ensure compliance with eClinical Solutions and industry quality standards, guidelines and procedures
• Other duties as assigned

Take the first step towards your dream career. Here is what we are looking for in this role.  

Qualifications: 

• Master in Statistics or biostatistics preferred
• SAS® certification is preferred
• 10+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role preferred
• Strong experience with clinical study design development, analysis, and sample size determination
• Experience with development of randomization schedule including development of IVRS specifications, and guidelines for appropriate usage of randomization schedule
• Excellent knowledge of English and with clear, concise, and accurate communications, both written and verbal 
• Detail oriented, ability to multitask with strong prioritization, planning and organization skills
• Ability and experience of delegating tasks and leading projects. Experience of working on multiple clinical protocols at the same time
• Ability to balance conflicting priorities
• Strong knowledge of ICH guidelines and other guidelines such as GCP, and 21 CFR Part 11 from different regulatory agencies including FDA, and EMEA
• Experience in developing statistical analyses reports, and in conducting statistical analyses and reporting for various trial level deliverables including but not limited to blinded data reviews, interim analyses
• Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes
• Knowledge of CDISC® related data models such as SDTM, and ADAM. Ability to develop ADAM model for analysis and reporting of clinical trial. Through understanding of SDTM data structures

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical is a winner of the 2025 Top Workplaces USA Award for Remote Work! We have also received numerous Top Workplaces Culture Excellence Awards celebrating our exceptional company vision, values, and work-life balance. See all the details here: https://topworkplaces.com/company/eclinical-solutions/

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for an Senior Biostatistician Consultant to join one of our clients in V&I (Vaccines & Infectious disease ) department 

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Role Overview:

We are seeking an experienced Senior Statistician Consultant to support clinical development programs within the Vaccines & Infectious Diseases (V&I) therapeutic area. The role involves leading statistical strategy, analysis, and reporting for clinical trials, ensuring high-quality deliverables aligned with regulatory standards.

Key Responsibilities:

• Lead statistical input for clinical trial design, including protocol development and sample size calculations
• Develop and review Statistical Analysis Plans (SAPs)
• Provide oversight of statistical analyses for clinical studies (Phase I–IV)
• Collaborate with cross-functional teams including Clinical, Data Management, and Programming
• Interpret study results and contribute to clinical study reports (CSRs)
• Support regulatory submissions (e.g., FDA, EMA) including responses to health authority queries
• Guide and review work of statistical programmers (SDTM/ADaM, TLFs)
• Ensure compliance with CDISC standards and regulatory guidelines
• Participate in safety and efficacy analyses, including interim analyses
• Provide strategic input for ISS/ISE and integrated analyses

Required Qualifications:

• Master’s or PhD in Statistics, Biostatistics, or related field
• 5+ years of experience in clinical trials within pharma/CRO
• Strong experience in Vaccines & Infectious Diseases
• In-depth knowledge of clinical trial methodology and statistical principles
• Experience with regulatory submissions (FDA/EMA)
• Proficiency in SAS; knowledge of R is a plus
• Strong understanding of CDISC (SDTM/ADaM) standards
• Excellent communication and stakeholder management skills

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Senior#Contract

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds...

ClinChoice is currently recruiting for a Senior Statistician to join our team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment.

Job Summary

We are seeking a highly skilled Senior Statistician to support and lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams.

Key Responsibilities

• Lead and provide statistical support for clinical studies, primarily within Immunology or any therapeutic areas

• Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables

• Author and review key statistical documents, including:

  • Statistical Analysis Plans (SAPs)

  • Analysis Database Specifications (ADS)

  • Statistical sections of clinical study reports

• Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance

• Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory

• Provide guidance and oversight to statistical programmers as needed

• Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders

• Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs

Required Qualifications

• MS or PhD in Statistics, Biostatistics, or a related field

• Strong experience in Immunology or any TA clinical studies 

• Hands-on experience writing:

  • Statistical Analysis Plans (SAPs)

  • Analysis Database Specifications

  • Reviewing and interpreting analysis results

• SAS programming skills required (hands-on or strong working knowledge)

• Excellent written and verbal communication skills

• Experience working in a CRO and/or pharmaceutical/biotech environment

Preferred Qualifications

• Experience leading Phase II–III clinical trials

• Prior interaction with regulatory agencies

• Experience mentoring junior statisticians or programmers

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Senior #Permanent

Forge Your Future with Us:

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins.

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases.

What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely, and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together.

At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us.

If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.

About The Role

The Scientist I (Statistics) supports the application of statistical methods to bioanalytical assay development, qualification, and validation activities within the Quality Control and Analytical Development functions. This role applies established statistical approaches to ensure data integrity, regulatory compliance, and accurate interpretation of analytical results. The Scientist I collaborates cross-functionally to support experimental design, data analysis, and documentation, contributing to the advancement of gene therapy programs.

What You'll Do:

· Apply established statistical methods to support development, qualification, and validation of bioanalytical methods (e.g., potency assays, ddPCR workflows)

· Perform statistical analyses for assay validation, including linearity, accuracy, precision, and detection limits

· Support stability studies through trend analysis, control charting, and regression modeling

· Assist in data review, interpretation, and troubleshooting for assay development and optimization activities

· Contribute to statistical analysis plans (SAPs), validation protocols, technical reports, and regulatory documentation

· Collaborate with cross-functional teams (QC, Analytical Development, Process Development, Regulatory)

· Support investigations, deviations, and root cause analyses with statistical input

· Assist in developing and maintaining data trending and reporting tools

· Ensure compliance with regulatory requirements (e.g., ICH, USP, FDA)

· Communicate statistical findings clearly to stakeholders

What You'll Bring:

• Ph.D. in Statistics or related field (or Master’s with relevant experience)

• 1–3 years of relevant experience in a biopharmaceutical, biotechnology, or analytical laboratory setting

• Experience with statistical software (JMP, SAS, R, Python)

• Strong analytical and problem-solving skills

• Effective written and verbal communication skills

• Ability to work independently within defined frameworks and collaborate across teams

Preferred Skills

• Familiarity with nucleic acid-based assays (e.g., ddPCR, qPCR)

• Experience with protein or cell-based assays (e.g., ELISA, flow cytometry)

• Experience in GxP-regulated environments

• Exposure to assay validation and stability studies

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

Work Environment and Physical Demands  

This position is performed in a temperature-controlled laboratory or office environment and requires regular standing, hand manipulation, and use of laboratory equipment. The role may involve lifting or moving materials up to 25 pounds and occasional reaching or handling at various heights. Appropriate personal protective equipment (PPE) must be worn when working with chemicals, biological materials, or in controlled environments.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

We’ve Got You Covered: 

At Forge Biologics, we believe our people deserve to be taken care of – in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:

Health from day one

• Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.

Time to recharge

• A competitive paid time off plan – because rest fuels innovation.
• 12 weeks of fully paid parental leave so you can focus on family when it matters most.

Rewarding your impact

• Annual bonus opportunities for all full-time team members.
• 401(k) with company match to help you plan for the future.
• Special employee discounts, including childcare and dependent care savings.

Your wellness, supported

• Onsite fitness facility at The Hearth.
• Mental health counseling and financial planning services through our Employee Assistance Program.
• Employer-paid short and long-term disability coverage to protect your peace of mind.

Fuel for your workday

• A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.

Grow with us

• Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.

Position Summary:

Reporting to the Executive Director, Statistical Programming, the Associate Director, Statistical Programming will be responsible for supporting Clinical Development programs by performing Statistical Programming tasks as well as building and computing the analytical programming environment.

Responsibilities:

• Oversee and work directly with CROs to provide guidance, effectively monitor and QC their deliveries for quality, time and budget adherence.
• Follow CDISC SDTM and ADaM standards and guidelines; validate SDTM, ADaM datasets and TFLs generated by the CRO.
• Work with the internal teams and CRO to prepare submission-readiness datasets (e.g. SDTMs, ADaMs) and metadata to support the BLA filing.
• Hands-on statistical programming to support CSR, publications, presentations, DSUR, IB update, safety data review, RTQ, and ad hoc analyses.
• Attend SMT and collaborate with the study statistician and other study team members in project planning and timeline discussions.
• Review key study documents including but not limited to study protocol, SAP, and CDM documents like CRF and DTA and provide inputs to represent statistical programming function.
• Work collaboratively with stakeholders and other developmental functions to standardize, maintain, and implement the data transformation and statistical analysis requirements.
• Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF) system acceptable for audit.
• Familiar with SAS server working environment and adherent to server and programming SOP.
• Proficiency in R for statistical analysis, data analysis, modeling, and data visualization

Qualifications:

• BS (10+ years) or MS (8+ years) in Statistics, Life Sciences, Computer Science or related fields and statistical programming experience in the pharmaceutical industry.
• Experience with immunological diseases is preferred.
• Excellent project and vendor management skills, directly managing CROs/vendors is preferred.
• Experience with BLA or NDA/sNDA with FDA (EMA is a plus).
• Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat; hands on experience with R and JMP is a plus.
• Extensive experience managing CROs for clinical and statistical programming activities
• Broad knowledge of medical/biological terminology in relevant therapeutic areas, good knowledge of drug development regulations for statistical analysis.
• Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.
• Great communication skills, with the ability to effectively develop and deliver strategically, while aligning and gaining the collaboration of cross-functional groups.
• Able to effectively lead functional and cross-functional projects of varying scope and complexity while prioritizing resource needs
• Strong hands-on programming skills to deliver results in a quick turnaround environment.

The Opportunity:

Playing a critical role as a lead statistician for clinical program(s) and studies and the subject matter expert (SME) in Biostatistics within Quantitative Sciences function, this position is to provide statistical leadership and support for clinical development strategy and clinical studies through product life cycle. 

• Provide statistical support and strategic input to clinical development plans and target product profiles, proof of concept criteria, and team’s preparation for company governance reviews.

• Represent Biostatistics function on cross-function teams at program level and serve as a lead statistician for oncology studies

• Collaborate with various functions on study design and planning, protocol development, statistical analysis plan and analysis specifications.

• Provide statistical support for study protocol development, analysis plan and specification through direct involvement and/or providing guidance to junior staff.

• Plan and prepare independent data monitoring committee (DMC), coordinate with independent statistical data analysis center for DMC and study team for periodic DMC reviews.

• Collaborate with data management and clinical operations over the course of clinical studies to provide statistical input to study conducts and database development as well as data collection and cleaning activities.

• Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.

• Provide statistical input and leadership to the development of global health authority documents, regulatory interaction and response to health authority submissions.

• Provide statistical support for clinical publications, assist in data interpretation to ensure consistency and accuracy in data presentation.

• Drive and lead department initiatives, best practices, and guidelines.

• Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.

Required Skills, Experience and Education:

• D. or M.S. in Statistics/Biostatistics, a minimum of 8 years (for Ph.D.) and 12 years (for M.S.) of experience in the biotech/pharma industry as a statistician. Level will be determined based on the relevance of experience.

• Hands-on experience in design and analysis of oncology trials is a must.

• Ability to work independently and within a team.

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Active participation in NDA/BLA filing through label negotiations desirable. #LI-Hybrid  #LI-SH1

The Opportunity:

This position is to serve as a study level statistician for oncology studies, and to coordinate activities with other functional groups to ensure timely deliverables. 

• Represent biostatistics on study/project teams.

• Provide statistical expertise for design, analysis and reporting of clinical studies.

• Collaborate with various functions on study design and planning, protocol development, statistical methodology and analysis.

• Develop statistical analysis plans and analysis specifications.

• Collaborate with statistical programming to ensure that analysis is conducted per statistical plan and specifications.

• Collaborate with data management and clinical operations to ensure robust CRF and database development and quality data collection.

• Provide statistical input to regulatory interaction and response to health authority submissions.

• Collaborate in publications, assist in data interpretation, and ensure consistency and accuracy in data presentation.

• Contribute to the development of functional-level standards, SOPs, and templates.

• Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 5 years (for Ph.D.) and 8 years (for M.S.) of experience in biotech/pharma industry as a statistician for clinical trials. Level will be determined based on the relevance of experience.

• Hands-on experience in design and analysis of oncology trials is a must.

• Ability to work independently and within a team.

• Ability to apply statistical knowledge to solve real-world problems and acquire new knowledge in advanced statistical methods (e.g., Bayesian methods, predictive modeling etc.).

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

#LI-Hybrid #LI-EM1

The Opportunity:

We are seeking a highly capable Associate Director of Biostatistics to join our Medical Analytics and Exploratory Data Science Biostatistics group within our Biostatistics organization. This role will play a critical part in the design, analysis, and interpretation of exploratory data analyses, scientific publications, real-world evidence (RWE), post-marketing research, and health economics and outcomes research (HEOR) studies. The successful candidate will serve as a key statistical contributor and emerging leader, partnering closely with cross-functional teams to deliver high-quality, data-driven insights that support scientific understanding and evidence generation.

• Lead statistical design, analysis, and interpretation for exploratory data analyses using existing clinical trial data, real world data studies, post-marketing research, and HEOR projects.

• Partner closely with other subfunctions within quantitative sciences and with cross-functional teams, including clinical development, medical affairs, safety, statistical programming, regulatory affairs and commercial, to execute evidence generation plans.

• Apply appropriate statistical methodologies, including survival analysis, machine learning, and casual inference approaches, to address complex scientific and medical questions in oncology.

• Contribute to the development of analysis plans, technical specifications, and interpretation of results under general direction from senior statistical leadership.

• Support cross-functional evidence generation planning by providing statistical input into study design, feasibility, and analysis strategies.

• Review and oversee statistical deliverables produced by internal programmers or external vendors/contractors to ensure scientific quality and consistency with standards.

• Contribute to and implement policies, standards, and procedures to ensure consistency and quality in statistical practices.

• Assist with the preparation of scientific communications, including abstracts, manuscripts, posters, and internal presentations.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 5 years (for Ph.D.) and 8 years (for M.S.) of experience in biotech/pharma industry as a statistician.

• Solid knowledge of statistical methodologies for oncology, including survival analysis and causal inference.

• Hands-on experience in exploratory analysis of oncology trials.

• Ability to work independently and within a team.

• Ability to independently execute statistical analyses for moderately complex projects with guidance from senior statisticians.

• Familiar with regulatory requirements related to biostatistical activities and clinical trials.

• Strong verbal and written communication skills are required.

• Strong interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Knowledge of RWD and health economics and outcomes research (HEOR) in oncology is a plus.

• Familiarity with machine learning or advanced modeling approaches applied to biomedical or observational data. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

We are seeking a highly motivated and scientifically rigorous Director of Biostatistics to our Medical Analytics and Exploratory Data Science Biostatistics group. This role will provide strategic and hands-on statistical leadership for exploratory data analyses, scientific publications, real-world evidence (RWE), post-marketing research, and health economics and outcomes research (HEOR) initiatives. The successful candidate will serve as a key statistical leader and individual contributor, partnering closely with cross-functional teams to generate high-quality evidence that advances our oncology pipeline and supports medical and scientific strategy.

• Provide statistical leadership for exploratory data analyses using existing clinical trial data, real world data studies, post-marketing research, and HEOR projects.

• Serve as a primary statistical contact for assigned projects, working collaboratively with clinical development, medical affairs, safety, statistical programming, regulatory affairs and commercial.

• Lead the design, analysis, and interpretation of complex statistical models, including survival analysis, machine learning, and casual inference methodologies.

• Contribute to and implement policies, standards, and procedures to ensure consistency and quality in statistical practices.

• Manage relationships with external partners, such as contract research organizations (CROs), ensuring adherence to timelines, budgets, and quality standards.

• Mentor and provide technical guidance to junior statisticians, fostering scientific rigor, innovation, and professional growth.

• Contribute to regulatory and payers/HTA agencies interactions, scientific publications, abstracts, and internal decision-making through clear and effective communication of statistical results.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, a minimum of 8 years (for Ph.D.) and 12 years (for M.S.) of experience in biotech/pharma industry as a statistician.

• Solid knowledge of statistical methodologies for oncology, including survival analysis and causal inference.

• Hands-on experience in exploratory analysis of oncology trials.

• Proven ability to independently lead statistical aspects of complex, cross-functional projects.

• Strong understanding of regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Excellent interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Knowledge of RWD and health economics and outcomes research (HEOR) in oncology is a plus.

• Familiarity with machine learning or advanced modeling approaches applied to biomedical or observational data. 

  #LI-Hybrid  #LI-SH1

The Opportunity:

Playing a critical role as a lead statistician for clinical program(s) and the subject matter expert (SME) in Biostatistics within the Quantitative Sciences function, this position is to provide statistical leadership and support for EU access strategies, healthcare technology assessments and regulatory submissions. 

• Serve as the statistical lead for European access strategies, ensuring alignment between Global Clinical Development, European regulatory (EMA, MHRA, Swissmedic...) and regional/local Market Access needs to support successful European launches in collaboration with global and regional crossfunctional teams.

• Partner with Regional and Local Market Access and HEOR functions to design and lead/oversee the execution of statistical analyses required for value dossiers, including PICO, indirect treatment comparisons, network meta-analyses, and RWE generation.

• Partner closely with the development statistical lead, provide statistical support for EU regulatory interactions, including EMA Scientific Advice, MAA, Type II variations, and post-authorization commitments.

• Ensure statistical methodologies align with EU guidance (ICH, EMA guidelines, CHMP expectations). 

• Contribute to the global statistical strategy, ensuring study designs and endpoints satisfy both regulatory approval and reimbursement dossier standards in Europe, proactively addressing diverse data requirements for payers across different European jurisdictions.

• Provide statistical expertise and support for regional study projects including study design, data analysis, and interpretation of results, to ensure high-quality and scientifically sound outcomes.

• Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.

• Drive and lead department initiatives, best practices, and guidelines.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics or related fields, a minimum of 10 years (for Ph.D.) and 15 years (for M.S.) of experience in the biotech/pharma industry as a statistician.

• Ability to work independently and within a team.

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Advanced methodological and technical skills.

• Strong problem solving and critical thinking abilities.

• Proficiency in SAS and/or R.

Preferred Skills:

• Strong track record in submitting with EMA filing with proven experience in supporting HTA submissions (e.g. to GBA, HAS) as well as reimbursement dossier contributions in major European markets.

• Experience in engaging with European scientific advice/early payer.

• Deep understanding of evolving landscape of EMA, MHRA and Swissmedic, and the evolving landscape of joint clinical assessments (JCA) in Europe, in addition to European legislation requirements.

• Active participation in NDA/BLA filing through label negotiations advantageous.

• Hands-on experience in design and analysis of oncology trials.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. #DNI

The Opportunity:

Playing a critical role as a lead statistician for clinical Late-Stage program(s) and the subject matter expert (SME) in Biostatistics within Quantitative Sciences function, this position is to serve as a program level lead statistician and provide statistical leadership and support for clinical development strategy and programs through product life cycle.

• Lead strategic, statistical thinking and contributions to clinical development plans.

• Represent Biostatistics function on cross-function teams at program level and serve as a lead statistician for oncology studies.

• Collaborate with various functions on study design and planning, protocol development, statistical analysis plan and analysis specifications.

• Provide statistical support for study protocol development, analysis plan and specification through direct involvement and/or providing guidance to junior staff.

• Plan and prepare independent data monitoring committee (DMC), coordinate with independent statistical data analysis center for DMC and study team for periodic DMC reviews.

• Collaborate with data management and clinical operations over the course of clinical studies to provide statistical input to study conducts and database development as well as data collection and cleaning activities.

• Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.

• Provide statistical input and leadership to the development of global health authority documents, regulatory interaction and response to health authority submissions.

• Provide statistical support for clinical publications, assist in data interpretation to ensure consistency and accuracy in data presentation.

• Drive and lead department initiatives, best practices, and guidelines.

• Keep abreast in new developments in statistics, drug development, and regulatory guidance and share knowledge with functional and cross-functional team members.

Required Skills, Experience and Education:

• Ph.D. or M.S. in Statistics/Biostatistics, minimum 10 years (for Ph.D.) and 14 years (for M.S.) of experience in biotech/pharma industry as a statistician. Level will be determined based on the relevance of experience.

• Extensive experience in design and conduct of phase 3 oncology trials.

• Solid knowledge in ICH and other regulatory requirements related to biostatistical activities and clinical trials.

• Excellent verbal and written communication skills are required.

• Good interpersonal and project management skills are essential.

• Proficiency in SAS and/or R.

Preferred Skills:

• Experience with lead role in NDA/BLA filing desirable. 

  #LI-Hybrid  #LI-SH1

RDQ427R169

While candidates in the listed locations are encouraged for this role, we are open to remote candidates in other locations.

Databricks is looking for a Principal Data Scientist to serve as the statistical voice of the Data Science organization. This person will make Databricks smarter and more data-driven at the highest levels of leadership — translating the full power of data science into clear, actionable narratives for our CEO, C-suite, and Board of Directors.

Our vision is simple: data drives every Databricks decision and action. To get there, we need a world-class statistician and communicator — someone who can bridge the gap between deep analytical rigor and executive decision-making. This is a pure IC role with company-wide influence: no direct reports, maximum leverage.

Databricks was founded in 2013 by the original creators of Apache Spark, Delta Lake, and MLflow. We built the Databricks Data Intelligence Platform to help organizations unify their data, analytics, and AI workloads. With more than 10,000 organizations worldwide — including over half of the Fortune 500 — relying on Databricks, and a team of 7,000+ employees, we are at the forefront of the data and AI revolution. We have been recognized as a leader by Gartner, Forrester, and IDC, and have raised more than $4 billion in funding at a $62 billion valuation.

The Impact You Will Have

• Executive translation. Translate complex data science findings into clear, actionable narratives for the CEO, C-suite, and Board of Directors — ensuring data science insights directly inform the company's most critical decisions.
• Statistical authority. Serve as the company's chief statistical voice and the final quality backstop for analytical rigor in high-stakes executive decisions. Advance the state-of-the-art in how Databricks applies statistical methods to business problems.
• Org-wide uplevel. Raise the communication bar across the entire Data Science organization by setting standards, coaching teams, and co-authoring key executive-facing deliverables. Make every DS team better at telling their story.
• Strategic insights. Produce deep strategic analyses on revenue, platform health, operational efficiency, and competitive positioning — the kind of synthesized, judgment-rich insight that AI cannot autonomously create.
• Cross-functional influence. Partner with engineering VPs, product leaders, and executive staff to embed a data-driven decision-making culture across the company. Be the trusted analytical advisor in rooms where critical decisions are made.
• External thought leadership. Represent Databricks externally as a data science thought leader at industry conferences, in publications, and in the broader statistical community. Build an external identity that attracts world-class talent.
• Methodology and standards. Define and evolve company-wide scientific methodologies — experimentation frameworks, forecasting systems, causal inference approaches — to match and push industry state-of-the-art.

What We Look For

Required

• 15+ years of experience in data science, statistics, or quantitative research spanning industry and/or academia.
• Proven track record of presenting statistical and data science concepts to C-suite and Board-level audiences, with measurable impact on executive decision-making.
• Broad expertise across data science disciplines: experimentation, causal inference, forecasting, optimization, and machine learning.
• Exceptional written and verbal communication — the ability to make complex statistical concepts intuitive and compelling for non-technical executives.
• Track record of upleveling teams: setting analytical standards, mentoring senior data scientists, and improving org-wide output quality.
• Experience at the intersection of statistics and large-scale technology or data platforms.
• Ph.D. in Statistics, Mathematics, Computer Science, or a related quantitative field.

Preferred

• Academic research or teaching background in statistics or a quantitative field.
• Industry experience at multiple tier-1 technology companies.
• Published research or recognized thought leadership in applied statistics.
• Experience building or leading a "Chief Statistician" or equivalent function.
• Experience in infrastructure, platform, or systems-oriented data science.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.  

Main Job Tasks and Responsibilities: 

The Senior Statistical Programmer Consultant is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks

Key Responsibilities: 

• Responsible for supporting the Programming deliveries of a clinical study or project.
• Implements statistical programming aspects of the protocol and the clinical development program.
• Ensures high quality is built into own deliverables and the quality delivered by other programmers.
• Programs independently with high efficiency and quality.
• Writes and/or implements specifications and oversees completeness of relevant documentation.
• Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
• Ensures compliance with standards and automation usage.
• Plans and support team activities and tasks.
• Communicates and escalates risks within the assigned studies and/or projects.
• Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader.

Education and Experience:

• Bachelor’s degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master’s degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
• Need to have Oncology TA experience.
• Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology.
• Good understanding of the clinical drug development process.
• Strong communication skills and coordination skills.
• Current knowledge of technical and regulatory requirements relevant for the role
• Ability to proactively manage concurrent activities within a project
• Proficient ability to influence relevant stakeholders on programming-related items

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Senior #Contract

Job overview:

The Senior Statistical Programmer will contribute expert programming skills to deliver accurate, regulatory-compliant clinical data outputs for Compass Pathways development programs. The role requires strong technical proficiency, collaboration across teams, and adaptability to support complex clinical trial requirements.

Location: Hybrid in our NYC Office or remote in the East Coast.

Reports to: Associate Director, Statistics and Data Management.

Duration: 9-month contract.

Roles and Responsibilities
(Include but are not limited to):

• Leading and coordinating the programming activities within agreed timelines
• Managing the reporting of studies internally and externally
• Programming outputs as stated in the analysis plan
• Working closely with study team members, mainly with the study statistician
• Reviewing of the Statistical Analysis Plan (SAP) and shells
• Create and review SDTM and ADaM study specifications
• Ensure programs, datasets, outputs are appropriate for regulatory submission
• Perform simulations and data modelling
• Perform Interim analyses
• Liaise with external vendors on deliverables

Candidate Profile:

• Extensive years experience in statistical programming
• CDISC expertise
• Proficient in programming including performing statistical analyses and creating macros in SAS, preferably R
• Programming/reporting expertise across all phases of clinical development (efficacy/safety/PK), including ISS/ISE reporting
• Experience in performing quality control (QC) checks
• Extensive knowledge in regulatory submission process
• Good understanding of ICH guidelines and regulations such as 21 CFR Part 11
• Experience supporting NDA submissions e.g., FDA, EMA, MHRA and addressing regulatory questions
• Ability to solve challenging problems and provide recommendations to mitigate risk
• Good communication skills - both written and verbal
• Team work skills - Including cross-functional and within the Statistics and Data Management Team

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for an Senior/Principal Biostatistician-Medical Affairs Consultant to join one of our clients. 

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. 

Summary

We are seeking a highly skilled Senior Statistician to support Medical Affairs activities, including post-marketing studies, real-world evidence (RWE) generation, and observational research. This role will partner closely with cross-functional teams to provide statistical expertise and ensure high-quality data analysis and interpretation.

ey Responsibilities

• Provide statistical support for Medical Affairs studies, including:
  • Observational studies
  • Real-world evidence (RWE) studies
  • Post-marketing and Phase IV studies
• Contribute to study design, protocol development, and statistical analysis plans (SAPs)
• Perform and/or oversee statistical analyses and ensure accuracy and quality of outputs
• Collaborate with Medical Affairs, Clinical, Epidemiology, and HEOR teams
• Interpret study results and contribute to clinical study reports, publications, and presentations
• Ensure compliance with regulatory and internal standards
• Support publication strategy and scientific communication activities
• Mentor junior statisticians, if applicable

Qualifications

• Master’s or PhD in Statistics, Biostatistics, or a related field
• 5–8+ years of relevant experience in the pharmaceutical, biotech, or CRO industry
• Strong experience in Medical Affairs / RWE / observational studies
• Proficiency in SAS and/or R
• Experience with study design, statistical modeling, and data interpretation
• Knowledge of regulatory guidelines and industry standards

Preferred Qualifications

• Experience in Immunology / Oncology / relevant therapeutic area
• Prior experience supporting publications and external communications
• Strong stakeholder management and communication skills

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Senior#Contract

Company Overview 

Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s lead program in clinical development is Pociredir, a small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease (SCD).

Description

Reporting to VP of Biometrics, the Director of biostatistics within the Biometrics Department is a hands-on role and is expected to be the statistics subject matter expert for clinical development programs and studies, including oversight of statistical activities in outsourced clinical trials, while ensuring adherence to all regulatory requirements. This individual is expected to have an in-depth understanding of innovative study designs and statistical methodologies, including estimand strategies, endpoint selection, missing data and multiplicity handling. In addition, this individual will have the capacity to understand the relevant multi-disciplinary knowledge and interact effectively within the biometrics department and with clinical development, clinical operations, pharmacovigilance, medical writing, and regulatory affairs.

Responsibilities

• Function as a lead statistician for internal studies.
• Contribute to enterprise strategy through proactive cross-functional collaborations and influence through decision making.
• Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address statistical questions from regulatory agencies.
• Conduct ad-hoc analyses as needed.
• Provide oversight of biostatistics activities in outsourced clinical trials.
• Ensure high quality, timely delivery of statistical analysis plans and statistical outputs.
• Execute quality assurance procedures on work produced by others, ensuring statistical analysis is being done according to specifications.
• Provide support for publications as needed.
• Author or review statistical SOPs and Working Instructions.

Qualifications

• A Ph.D. (or equivalent degree) in Biostatistics or Statistics with a minimum of 8 years of relevant clinical biostatistics experience in pharma, biotech or CRO industry -OR- a Master's degree and a minimum of 10 years of relevant industry experience is required.
• Comprehensive knowledge of innovative study design and statistical methodologies.
• Extensive knowledge of relevant clinical and statistical regulatory requirements (e.g., GCP, ICH, CDISC, etc.).
• Regulatory interaction and submission experience is highly preferred.
• Experience in oversight of biostatistics activities in outsourced clinical trials is highly preferred.
• Proficiency in statistical software (e.g., SAS, R) and simulation.
• Excellent verbal and written communication skills.
• Ability to work collaboratively in a multidisciplinary team environment.

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for an Principal Biostatistician Consultant to join one of our clients. 3 days Hybrid at Malvern PA. 

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. 

JOB SUMMARY:

This contract principal statistician will work with Biometrics director to manage one or more compounds/Indications in R&D for the entire life cycle. He/she will be responsible for all statistical aspects of the drug development and/or post-approval programs. These responsibilities include Regulatory interactions, study design, statistical methodology, analysis, regulatory submission, and/or pre- and post-approval activities.  He/she will coordinate statistical and programming support and will manage contractors/CROs when necessary. He/she will also serve as lead statistician for clinical studies and work with the study team  members effectively.

KEY ACCOUNTABILITIES:
Drug Development 

• Provide inputs to clinical team on the design, analysis and interpretation of scientific data from Phase I to IV clinical trials, ISS and ISE.
• Collaborate with the project team to design the protocols (synopses and full) and provide sample size calculations.
• Draft or review the SAP and the associated mock TLF.
• Performs review of TLFs to ensure that they are accurate within and across outputs for a particular deliverable (e.g., CSR, IDMC, publication).
• Provide statistical support for other functions within the organization (i.e.., Medical Affair, Regulatory, or others).
• Manage project timelines and interact with external vendors.

Communication:

• Conduct DAR meeting prior to database lock or Comment resolution meeting.
• Prepare the presentations and interpret the results.
• Participate in data review meetings within the organization.

Process Improvements:

• Be Compliant with all trainings and SOPs.
• Contributes to intra- and interdepartmental process improvement activities to achieve “best practices”

Mentoring:

• Mentor entry-level team member if needed
• Manage internal and external employees/contractors

Education:

• Continuously seek knowledge regarding most current statistical methods.
• Prepare presentations for internal and external audiences (presenting at key statistical meetings).

QUALIFICATION:

• M.S. or Ph.D. (or equivalent) in Statistics or Biostatistics is required.
• Minimum 4 years (Ph.D.) or  8 years (M.S.) pharmaceutical industry experience
• Should possess experience interacting with regulatory agencies (e.g. FDA, MHRA or EMEA).
• Experience managing multiple projects/therapeutic areas.
• Experience in managing external vendors (e.g. contractors, CROs).
• Capability in working independently and lead one or multiple clinical studies. 

Knowledge

• Solid background of statistics
• Experience of SAS, R and other statistical programming packages to validate key endpoint analysis.
• Possess extensive knowledge of the Drug Development Process.
• Possess extensive knowledge of regulatory policies and procedures.

Skills & Abilities:

• Ability dealing with ambiguity.
• Ability to handling stress.
• Drive for results.
• Ability to prioritize.
• Ability to establish and maintain effective working relationships with team members, managers, and partners.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

#LI-TT1 #LI-Remote #Principal#Contract

Your Impact:

Rapport is seeking an Associate Director / Director of Biostatistics who will have a hands-on role in shaping the design, analysis, and interpretation of clinical trial data for our precision neuromedicine programs. Reporting to the Head of Biostatistics, you will collaborate closely with multidisciplinary teams to advance groundbreaking therapies, ensuring statistical rigor and the highest standards of data integrity throughout the drug development process.

Your Day-to-Day:

• Working as a leading statistician on multiple studies/projects. Oversee the production of protocol development (study design, endpoint selection, sample size calculation and statistical methods) and Statistical Analysis Plan (SAP) that lead to comprehensive clinical study reports suitable for regulatory submissions.
• Leads collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enables successful impact on robust drug development plans
• Support statistical programming to plan, execute and deliver SDTM and ADaM datasets, tables, listings, and figures (TLFs). Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines (ICH, FDA, EMA).
• Provide statistical input and the interpretation of results to clinical study reports, regulatory submissions documents, and publications, in collaboration with the clinical, regulatory, and medical affairs teams.
• Perform and validate statistical analyses of clinical trial data using SAS and/or R in accordance with regulatory and internal standards.
• Participate in the development and review of case report forms (CRFs) and data management plans to ensure accurate data collection aligned with study objectives.
• Oversee and manager external CROs and vendors to ensure high-quality and timely deliverables.
• Participate in cross-functional team meetings, providing statistical support and insights to influence decision-making.

Must-Haves:

• Associate Director: PhD with 6+ years or MS with 9+ years of biostatistics experience
  • Director: PhD with 9+ years or MS with 12+ years of biostatistics experience
• CNS therapeutic area experience is a plus
• Skilled in scientific programming including SAS or R, or Python for data analysis, graphing, and simulation
• Comprehensive knowledge of clinical trial design, advanced statistical analysis methods, and familiarity with regulatory guidelines (FDA, EMA, ICH)
• Extensive knowledge with CDISC standards (SDTM, ADaM) and industry best practices for data collection, analysis, and reporting
• Ability to communicate complex statistical concepts clearly to non-statistical audiences.
• Ability to manage multiple projects in a fast-paced environment, flexibility to adapt to changing priorities and timelines
• Ability to effectively collaborate with internal stakeholders and manage the statistical work of external stakeholders/vendors

What makes Rapport special:

• Every role has meaning. We’re determined to discover a better way for patients, and you’ll feel the passion from the start.
• We are driven to innovate. Exciting science that pushes boundaries and opens new possibilities.
• Your perspective matters. Stick your neck out, share your ideas – we work as a team.
• We have FUN. We hire smart, dedicated, down-to-earth people that you’ll enjoy spending time with.
• Leadership that CARES – about you, your growth + development.
• We're bicoastal. Whether you're in the lab full-time in San Diego or taking advantage of a more hybrid work schedule in Boston – we make the most of our time together.
• Competitive benefits. Including unlimited PTO, a lifestyle spending account, commuting reimbursement, and much more!
• You get to be YOU! Show up as you are and make every day count.

Your Compensation:

We get it. Compensation is an important part of your offer. You shouldn’t be surprised at the end of the recruiting process, and you should know that your offer is fair and equitable. How do we do this?  We tell you about our hiring range now - we expect the hiring range for this role to be $190,000-$220,000 for the Associate Director level and $230,000-$250,000 for the Director level. Our actual offer will reflect a lot of factors including your relevant skills, experience, location, salary market data, and internal equity. In addition to a competitive salary, we also offer a pretty great benefits package. We don’t stop here - if you join Rapport, we go to the next level. We share our full salary ranges for every level across our company. 

Hybrid Work Environment:

This role has the ability to be fully remote. If you are located in the Boston area, we prioritize in person connection with our fellow Rapptors! Our team members come together onsite at our Boston office on Monday, Tuesday and Wednesday to create more opportunities for innovation, collaboration, and connection.

Who we are:

Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn. 

How we work:

• PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
• COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
• BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

How you’ll make an impact:

As the Lead Statistician, you will spearhead the statistical efforts of one or more clinical programs, playing a key role in the clinical development plan, regulatory submissions, and overall data strategy. This role requires strategic involvement in program teams, authorship of statistical sections in study documents, and direct oversight of outsourced statistical functions.

• Act as the lead statistician of a clinical program, leading statistical efforts and representing biometrics functions on program teams. Make strategic contributions to the clinical development plan.
• Serve as the biostatistical lead for regulatory submissions and inspections, ensuring compliance with global regulatory standards.
• Contribute to the development of clinical protocols by authoring the statistical methods section and reviewing other sections for statistical accuracy.
• Develop and review statistical analysis plans for individual studies and integrated summaries of safety/efficacy (ISS/ISE). Create and edit statistical outputs shells.
• Provide statistical input during CRF design to ensure alignment with study objectives and analyze requirements. Oversee and quality control results from statistical programmers or CROs.
• Contribute to clinical study reports by authoring statistical sections and interpreting study results. Support the preparation of scientific publications and presentations.
• Manage relationships with CROs to ensure high-quality statistical outputs and compliance with study requirements.
• May manage direct reports, as needed, providing guidance and professional development.

Skills and experience you’ll bring:

• Advanced degree in Statistics or related field with minimum 6 years of clinical trial experience in a biotechnology or pharma company.
• Extensive knowledge of statistical methods for clinical trials and deep familiarity with FDA, EMA, and ICH guidelines.
• Expertise in SAS required; R or Python is advantageous. Experience with trial design software such as EAST or nQuery.
• Strong communication skills necessary for effective collaboration with cross-functional teams. Ability to communicate statistics to non-statisticians effectively; influence and ensure adoption of robust statistical methods.
• Exceptional ability to manage multiple priorities in a fast-paced environment.
• A strong passion for innovation in Biostatistics and continuous improvement in processes.
• Strong analytical and problem-solving abilities.
• Positive attitude and a collaborative spirit.

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

Compensation

• Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
• The anticipated base salary range for this role is $195,000 – $275,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
• Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.

Job overview:

The Senior Statistical Programmer will contribute expert programming skills to deliver accurate, regulatory-compliant clinical data outputs for Compass Pathways development programs. The role requires strong technical proficiency, collaboration across teams, and adaptability to support complex clinical trial requirements.

Location: United Kingdom home based or hybrid in our London Office.

Reports to: Associate Director, Statistics and Data Management.

Type: Fixed-term contract for 9 months.

Roles and Responsibilities
(Include but are not limited to):

• Leading and coordinating the programming activities within agreed timelines
• Managing the reporting of studies internally and externally
• Programming outputs as stated in the analysis plan
• Working closely with study team members, mainly with the study statistician
• Reviewing of the Statistical Analysis Plan (SAP) and shells
• Create and review SDTM and ADaM study specifications
• Ensure programs, datasets, outputs are appropriate for regulatory submission
• Perform simulations, data modelling and interim analyses
• Liaise with external vendors on deliverables

Candidate Profile:

• Extensive years experience in statistical programming
• CDISC expertise
• Proficient in programming including performing statistical analyses and creating macros in SAS, preferably R
• Programming/reporting expertise across all phases of clinical development (efficacy/safety/PK), including ISS/ISE reporting
• Experience in performing quality control (QC) checks
• Extensive knowledge in regulatory submission process
• Good understanding of ICH guidelines and regulations such as 21 CFR Part 11
• Experience supporting NDA submissions e.g., FDA, EMA, MHRA and addressing regulatory question
• Ability to solve challenging problems and provide recommendations to mitigate risk
• Good communication skills - both written and verbal
• Team work skills - Including cross-functional and within the Statistics and Data Management Team

Role Summary:

The Sr. Director of Biostatistics will provide leadership and strategic input for clinical development programs assigned. The selected individual will be responsible for statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. This is a hands-on role where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, conduct ad-hoc analyses, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files.

Key Responsibilities:

• Lead the biometrics team including statistician, data manager, and statistical programmer at a program level.
• Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies.
• Promote research of advanced and innovative statistical methods to increase probability of success of clinical studies.
• Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings.
• Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager to ensure high-quality data.
• Participate in cross-functional study-related activities; Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance ＆ Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines.
• CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines. Ensure deliverables are accurate and delivered according to timelines.
• Global Health Authority Interaction: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities.
• Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc analyses.
• Build and develop efficient biostatistical processes and standards.
• Other duties as assigned.

Ideal Candidate:

• PhD Degree in Biostatistics, Statistics, or a related field with at least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry.
• Strong knowledge of statistical methodologies and their application in clinical trials and health research. Working knowledge of Bayesian methodology and causal inference is preferred.
• Experience with regulatory submissions and interactions with regulatory agencies.
• Proficiency in statistical software (e.g., SAS, R) and data management systems.
• Experience with CDSIC including SDTM, ADaM, CDASH.
• Successful track record of working independently in a matrixed organization and providing solutions to emerging problems.
• Excellent communication and interpersonal skills, along with organizational skills.
• Ability to work collaboratively in a multidisciplinary team environment.
• Experience in people management is preferred.
•  

What We Offer:

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $275,000 to $290,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location. 

About Us: At Emendata, we help bridge the gap between data and the real world. We partner with organizations that have a social mission and help them tackle their problems using analytics. Our role in these partnerships goes end to end—we handle everything from wrangling the data to analyzing the problem to turning the results into something actionable. We know that this analytics pipeline does not live in a vacuum. Getting to meaningful numbers requires more than just the right methods; it calls for understanding the people, policies, data, and systems involved. 

With this approach, our small but fast-growing team is having a big impact taking on challenges in healthcare program integrity – safeguarding programs like Medicare and Medicaid by preventing fraud, waste, and abuse. We are growing our team with people who enjoy figuring out hard problems, want their work to matter, and set a high bar for themselves and their teammates.

About the Role: For this role, we are looking for someone to serve as a technical lead on statistical projects analyzing healthcare programs. This position is responsible for translating high-level direction from management or clients into studies/analyses that leverage statistically robust methods. We are looking for you to:

• Operationalize research questions from management and clients into robust analytic frameworks, research activities, and deliverables with minimal direction
• Apply a broad set of statistical methods to analyze and interpret data, including survey data, health records, and other administrative data
• Prepare research for dissemination to a variety of technical and non-technical audiences; produce materials (e.g., reports, presentations) that summarize the data and methodology, interpret analytic findings, and provide conclusions and recommendations
• Support project teams internally by providing input on study design and application of statistical methods
• Support development of data analysts through technical mentoring, code review, trainings, and other assistance
• Continue growing subject matter expertise by staying up-to-date on the latest statistical techniques and applications; contribute to the development of the company’s institutional knowledge
• Engage with stakeholders to understand client needs/priorities, business processes, program policy, data, etc. 

Required Qualifications: We are looking for you to have the following qualifications:

• Education: M.S. or Ph.D. in statistics or related field
• Experience: 2+ years applied research experience with statistical sampling and applying statistical models
• Technical Expertise: Strong familiarity with statistical sampling, probability, regression modeling, and practical applications
• Programming: Experience performing analyses using Python, R, or SQL 
• Communication: Ability to write clearly and communicate effectively with technical and non-technical audiences
• Interests: Strong interest in social science research
• Working Style: Capable of working with minimal supervision and a high level of initiative; practical approach to problem-solving; comfortable working both independently and collaboratively on client-facing projects 

Desired Qualifications: If you do not meet all the criteria below but still think you would be a good fit for this role, please apply so we can see if we can find the right spot for you on the team.

• Experience: Strong track record of research excellence in a professional setting (experience in consulting preferred)
• Technical Expertise: Familiarity with artificial intelligence and machine learning methods, tools, and practical applications a plus
• Domain Expertise: Knowledge of healthcare data, policy, and program integrity efforts strongly preferred (e.g., Medicare policy, CMS data)

This position is full-time onsite in San Francisco. Working side by side accelerates learning, mentorship, and the kind of collaboration that leads to producing our best work. Additionally, to be considered for this position, applicants must have the ability to work in the U.S. without a need for current or future visa sponsorship. Staff will be required to complete a successful background investigation, including the Questionnaire for Public Trust Position SF-85.Pursuant to the San Francisco Fair Chance Ordinance, all qualified applicants with arrest and conviction records will be considered for employment.

Position Summary

ANSER is seeking a Senior Computer Scientist to support AI/ML Quality Assurance Framework (QAF) efforts by integrating mathematics, statics, information science, AI, network science, probability modeling, data mining, data engineering, data warehousing, data compression, data protection, and/or other scientific techniques to correlate complex, technical findings into graphical, written, visual and verbal narrative products on trends of existing intelligence data to leverage other IC data sources.

Day-to-Day Responsibilities

• Design and execute Testing, Evaluation, Verification, and Validation (TEW) protocols
• to evaluate the performance, robustness, and fairness of AI systems in all source analysis ’contexts.
• Collaborate with the Statistician/Mathematician to develop and apply statistical models and methods to analyze TEW results and identify areas for improvement.
• Develop and implement corrective actions to address TEW findings and ensure AI
• system performance and robustness.
• Develop and implement AI system maintenance schedules to ensure continued system performance and robustness.
• Collaborate with stakeholders to identify and prioritize AI system improvements and updates.
• Develop and implement AI system updates and improvements to ensure compliance with
• tradecraft standards and best practices.
• Conduct technical assessments to ensure compliant use of AI systems for approved use
• cases in all source analysis.
• Evaluate AI system performance and adherence to tradecraft standards, and identify areas for improvement.
• Develop and maintain a repository of audit findings and recommendations to facilitate
• knowledge sharing and best practices across the organization.
• Support capability development by contributing, editing, and storing code in
• Government owned/controlled source version control repositories.
• Employ data science techniques to support predictive analysis, social across the Defense Intelligence Enterprise (DIE).

Required Qualifications

• TS/SCI with Poly Clearance
• Master’s degree in Data Science, Computer Science, Statistics, Mathematics, or related technical field.
• Twelve or more years of related experience in data science, analytics, or machine learning in support of intelligence or defense missions.
• High Proficiency in Python, R, and SQL, and experience with data visualization tools such as Power BI or Tableau.
• Strong knowledge of TEVV methodologies, bias detection, and fairness analysis for AI systems.
• Experience with predictive modeling, data mining, statistical analysis, and ML algorithms.
• Experience with knowledge graphs, semantic data modeling, and query languages (e.g., SPARQL, GraphQL).
• Experience developing, implementing, and evaluating AI/ML models for analytic efficiency and tradecraft compliance.
• Understanding of DoD 8570/8140 compliance standards for computer science and cybersecurity roles.

Preferred Qualifications

• Experience supporting DIA, IC, or DoD analytic modernization or OBI initiatives.
• Experience with distributed data processing, cloud-based analytics, or large-scale machine learning architectures.
• Demonstrated understanding of Object Based Intelligence frameworks.
• Experience with DoD 8570/8140 compliance and responsible AI policy frameworks.
• Experience working with in support of Defense Intelligence All-source Analytic Enterprise (DIAAE) OBI efforts, the Defense Intelligence Enterprise Knowledge Model (DIEKM), and Defense Intelligence Core Ontology (DICO).

The Official Scorer makes and announces all game decisions involving judgment calls based on Rule 9 of the Official Baseball Rules, clarifying scoring rules interpretation to club and media personnel when necessary.  Approves the official game report transmitted to MLB’s Official Statistician (Elias Sports Bureau) post-game.

We are actively recruiting for the following markets:

• Atlanta, Denver, Detroit, Kansas City, Los Angeles, Miami, Phoenix, and Tampa Bay. 

Responsibilities

• Arrive at the ballpark no later than 60 minutes prior to the scheduled start time
• Collect rosters and other applicable information, test the press box microphone, and be set up before the first pitch
• Keep a detailed scorecard of the game, focusing on every pitch and play
• Make announcements as expected of the Official Scorer (i.e., time of first pitch, fielding credits, winning and losing pitchers, etc.)
• Coordinate with the MLB Stringer, alerting them of all in-game judgment calls before announcing as well as coordinating approval of the official post-game report prior to its transmission to the Official MLB statistician
• Communicate with MLB Official Scoring in-game support when needed via Slack
• Provide a post-game recap detailing Scoring decisions and other applications of Rule 9 of the MLB rulebook
• Participate with in-season training when necessary and reasonably required
• Routine day-to-day correspondence via email, Slack, voice call, and/or text message, to keep current with coverage schedules and other scheduled assignments
• Other game-day responsibilities during the regular season and/or Postseason as determined by the Official Scoring supervisor(s)

Qualifications & Skills

• Exceptional (and demonstrable) knowledge of the Official Baseball Rules, and especially Section 9 of OBR
• Candidate should be available to score 20-30 games per season
• Effectively utilize approved online tools designed to enhance performance and communication with essential game personnel
• Ability to clearly communicate information via press box mic, and to effectively clarify Official Scoring Rules and scoring decisions, when necessary, to club officials and others
• Demonstrate good judgment on applicable plays requiring decisions
• Attention to detail in keeping a scorecard and tracking game totals for each player and team
• Demeanor to accept constructive criticism and instruction, and patience to deal with critique of performance from various parties (i.e., clubs, players, media)
• Collaborative spirit with colleagues at MLB, other Official Scorers, team officials, and others
• At many games, the Official Scorer may be the most visible representative of MLB and needs to conduct him or herself with appropriate dignity
• Previous Official Scoring experience in professional or amateur baseball is strongly preferred, but not required

Pay: $35.00 per hour

The actual offer will carefully consider a wide range of factors, including your work experience, education, skills, and any other factors MLB considers relevant to the hiring decision.

There is a correspondence training program before working any games solo in the ballpark.

ONLY those who reply to this link will be considered, and due to volume, we may be unable to respond to all applicants.