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

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.

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

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

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:

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:

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

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

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

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.