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 Clinical R Programmer Consultant to join one of our clients. 

We are seeking a Clinical R Programmer with strong experience in R and a solid background in clinical programming. The ideal candidate will have hands-on experience developing SDTM and ADaM datasets using R, along with working knowledge of SAS. This role requires someone who can support clinical trial deliverables, ensure regulatory compliance, and collaborate closely with biostatistics and clinical data teams.

Key Responsibilities

• Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards.
• Support TLF (Tables, Listings, Figures) generation in R or SAS as needed.
• Write efficient, reproducible, and well-structured R scripts for clinical data analysis and reporting.
• Collaborate with statisticians, data managers, and clinical teams to understand programming requirements.
• Perform QC checks, reconcile data issues, and ensure deliverables meet regulatory expectations (e.g., FDA, EMA).
• Contribute to programming workflows, documentation, and version control best practices.
• Support automation initiatives and R-based pipeline development.
• Utilize SAS for legacy studies or where SAS support is required.

Required Qualifications

• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
• 4–6+ years of experience in clinical programming, with a strong focus on R.
• Proven experience in creating SDTM and ADaM datasets using R.
• Working knowledge of SAS programming.
• Solid understanding of CDISC standards (SDTM, ADaM).
• Experience with clinical trial data, regulatory submissions, and QC processes.
• Strong analytical, problem-solving, and documentation skills.

Preferred Qualifications

• Experience with R packages such as tidyverse, haven, pharmaverse (e.g., admiral, tidyCDISC), or other clinical programming toolkits.
• Understanding of R Markdown, Shiny apps, or reproducible reporting tools.
• Exposure to GxP validation, version control (Git), and automated workflows.
• Experience working in a CRO or pharmaceutical environment.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a 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 are the core instruments 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 low industry-average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent, guided by a commitment to 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 Statistical Programmer to join our team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment.

Responsibilities

Programing for clinical trials:
Program and validate derived datasets, tables, figures, listings. Process data from the external sources.  
Perform ad hoc exploratory analyses for publications and programming support other functions of Research and Development or other organizations.
Oversee programing work/deliverables from CROs.
Contribute to the design/implementation/review of Case Report Form, Data Transfer Specification, Statistical Analysis Plan, SDTM/ADaM Specification documents, Define packages.

Electronic submissions:
Program and validate CDISC compliant deliveries for the electronic submissions.
Support in the creation of supporting documentation for submissions.

Project Management:
Ensure programming deliverables are on time and of high quality.
Help managing internal contractors and external vendors.

Standards and Guidelines:
Participate in development of departmental working instructions and guidelines.
Help in creation of enhanced functions/macros and utilities.  

Qualification & Experience 

• Bachelor or Master degree in Computer Science, Mathematics, Engineering, Medical or related discipline.
• BS with more than 5 or MS with 3 years of experience in statistical programming (SAS, R) in the pharmaceutical industry.
• Working knowledge of SAS and its various components.
• Knowledge of R programming in clinical trials
• Familiarity of the drug development process.
• Strong SAS and SAS Macro language skills.
• R programming skils in clinical trials
• Strong knowledge of industry standards.
• Ability to work on data integrations (ISS and ISE).
• Strong oral and written communication skills. Ability to communicate details of the analysis to other team members with less technical experience.

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 Statistical Programmer II/III 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 an experienced Statistical Programmer III with strong expertise in R programming to support clinical trial data analysis and reporting. The ideal candidate will have hands-on experience in developing, validating, and maintaining statistical outputs using R, along with a solid understanding of clinical data standards.

Key Responsibilities:

• Develop, validate, and maintain statistical programs using SAS for the generation of Tables, Listings, and Figures (TLFs)
• Perform data manipulation, analysis, and visualization using R/SAS and relevant packages
• Collaborate with Biostatisticians and Data Management teams to support clinical study deliverables
• Ensure compliance with regulatory standards and company SOPs
• Conduct quality control (QC) and validation of programming outputs
• Support submission activities and documentation as required

Required Skills & Qualifications:

• Bachelor’s or Master’s degree in Statistics, Biostatistics, Computer Science, or a related field
• 3+ years of experience in statistical programming within the pharmaceutical/biotech industry
• Hands-on experience with R programming in a clinical trial environment
• Good understanding of R packages. 
• Good understanding of CDISC standards (SDTM, ADaM)
• Strong knowledge of clinical trial data and regulatory requirements

Preferred Qualifications:

• Experience working in an FSP model or with global pharmaceutical clients
• Exposure to submission activities (e.g., FDA/EMA)
• Familiarity with SAS alongside R is a plus
• Strong problem-solving 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 currently recruiting for a Clinical Data Manager to join our team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment.

Role Overview:

We are seeking a detail-oriented Clinical Data Manager with 3–5 years of experience in a CRO or pharmaceutical environment. The role involves managing clinical trial data to ensure accuracy, integrity, and compliance with regulatory standards.

Key Responsibilities:

• Manage end-to-end clinical data management activities for assigned studies
• Design and review CRFs (Case Report Forms) and edit checks
• Oversee data collection, cleaning, and validation processes
• Perform data review and discrepancy management
• Coordinate with cross-functional teams (Clinical, Biostatistics, Programming)
• Ensure compliance with CDISC standards and regulatory guidelines
• Support database build, UAT testing, and database lock activities
• Generate and review data listings and reports
• Participate in data reconciliation (e.g., SAE, lab data)
• Ensure timely delivery of high-quality datasets for analysis and submission

Required Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field
• 3–5 years of experience in clinical data management within CRO/pharma
• Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle Clinical, Inform)
• Strong understanding of GCP, ICH guidelines, and clinical trial processes
• Familiarity with CDISC standards (SDTM)
• Good knowledge of data validation and query management
• Strong attention to detail and problem-solving 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 #Permanent

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

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 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. 

Location: 3 days hybrid at Malvern PA

Job Summary

The contract Senior Statistical Programmer is a member of the Biometrics Department within the Research and Development (R&D) organization who supports Statistical programming work in accordance with corporate standard operating procedures (SOPs), GCP, 21 CFR and ICH guidance.

Responsibilities

Programing for clinical trials:
Program and validate derived datasets, tables, figures, listings. Process data from the external sources.  
Perform ad hoc exploratory analyses for publications and programming support other functions of Research and Development or other organizations.
Oversee programing work/deliverables from CROs.
Contribute to the design/implementation/review of Case Report Form, Data Transfer Specification, Statistical Analysis Plan, SDTM/ADaM Specification documents, Define packages.

Electronic submissions:
Program and validate CDISC compliant deliveries for the electronic submissions.
Support in the creation of supporting documentation for submissions.

Project Management:
Ensure programming deliverables are on time and of high quality.
Help managing internal contractors and external vendors.

Standards and Guidelines:
Participate in development of departmental working instructions and guidelines.
Help in creation of enhanced functions/macros and utilities.  

Qualification & Experience 

• Bachelor or Master degree in Computer Science, Mathematics, Engineering, Medical or related discipline.
• BS with more than 5 or MS with 3 years of experience in statistical programming (SAS, R) in the pharmaceutical industry.
• Working knowledge of SAS and its various components.
• Knowledge of R programming in clinical trials
• Familiarity of the drug development process.
• Strong SAS and SAS Macro language skills.
• R programming skils in clinical trials
• Strong knowledge of industry standards.
• Ability to work on data integrations (ISS and ISE).
• Strong oral and written communication skills. Ability to communicate details of the analysis to other team members with less technical experience.

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

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.

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

We are seeking an experienced Principal Biostatistician to provide statistical leadership for oncology clinical development programs. This role will support Phase I–III clinical trials and contribute to regulatory submissions while collaborating closely with cross-functional teams.

Key Responsibilities

• Provide statistical leadership for oncology clinical trials across multiple phases (Phase I–III).

• Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs).

• Design and review statistical methodologies for efficacy and safety analyses.

• Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards.

• Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs.

• Collaborate with clinical development, data management, programming, regulatory, and medical teams.

• Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA).

• Provide strategic input on study design, endpoint selection, and sample size calculations.

• Mentor junior statisticians and provide technical guidance.

Qualifications

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

• 8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics.

• Strong experience in oncology clinical trials.

• Hands-on experience with survival analysis, time-to-event endpoints, and complex oncology study designs.

• Proficiency in SAS and/or R.

• Strong knowledge of CDISC standards (SDTM, ADaM).

• Experience supporting regulatory submissions.

• Excellent communication and leadership skills.

Preferred Qualifications

• Experience with adaptive designs and Bayesian methods.

• Prior experience interacting with regulatory agencies.

• Experience in immuno-oncology or hematology oncology.
  
  

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

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  Manager, Statistical Programming Consultant to join our client’s team —an exciting opportunity to lead impactful statistical strategy in a dynamic environment.

Role Overview

We are seeking an experienced and motivated Manager, Statistical Programming to lead programming activities within the Biometrics group. This role will oversee clinical programming deliverables, drive quality and compliance, support regulatory submissions, and mentor a team of programmers. The ideal candidate will have strong expertise in SAS (and/or R), deep knowledge of CDISC standards, experience with oncology clinical trials, and excellent leadership skills.

Key Responsibilities:

Leadership & Strategy

• Lead and mentor a team of statistical programmers, fostering development and high performance.

• Oversee internal and vendor/CRO programming deliverables, ensuring timelines and quality expectations are met.

• Establish and maintain programming standards, documentation, and best practices.

• Support planning, resourcing, and prioritization for programming activities across multiple studies.

Programming & Technical Delivery

• Oversee development and validation of SDTM and ADaM datasets according to CDISC standards and oncology study requirements.

• Supervise creation of Tables, Listings, and Figures (TLFs) for clinical study reporting and regulatory submissions.

• Ensure all deliverables are of high quality, reproducible, and aligned with regulatory expectations (e.g., FDA, EMA).

• Support automation and efficiency initiatives using SAS and/or R.

• Perform and review QC checks, resolving programming and data issues.

Cross-Functional Collaboration

• Partner closely with Biostatistics, Clinical Data Management, Medical Writing, and Regulatory teams.

• Participate in study team meetings, contributing programming perspective to clinical and data discussions.

• Support preparation of submission-ready deliverables, including reviewer guides, traceability documents, and regulatory artifacts.

Required Qualifications:

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field.

• 9–11+ years of statistical programming experience in the pharmaceutical/biotech/CRO environment.

• Strong proficiency in SAS programming; experience with R is a plus.

• Expert understanding of CDISC standards (SDTM, ADaM).

• Experience managing or mentoring programming teams.

• Demonstrated experience supporting regulatory submissions.

• Excellent communication skills and ability to work collaboratively across functions.
  
  

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 #Manager#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 a Principal Statistical Programmer Consultant to join one of our clients. 

The Principal Statistical Programmer will serve as a senior technical expert responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors. This role requires advanced expertise in SAS, familiarity with R, deep knowledge of CDISC standards, and strong experience working on oncology studies and regulatory submissions.

Key Responsibilities

Technical Leadership

• Lead programming activities for oncology clinical trials across multiple studies.

• Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines.

• Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions.

• Provide SAS programming expertise to support complex data derivations and analyses.

• Review and ensure traceability, consistency, and quality of all programming deliverables.

Project & Study Management

• Act as programming lead for assigned studies, managing timelines and deliverables.

• Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs.

• Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards.

• Support integrated analyses including ISS/ISE.

Regulatory & Submission Support

• Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.

• Ensure all programming meets regulatory requirements (FDA, EMA, PMDA).

• Contribute to responses for regulatory queries and data requests.

Required Qualifications

• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.

• 8–12+ years of statistical programming experience in pharma/biotech or CRO.

• Expert-level proficiency in SAS.

• Strong understanding of CDISC SDTM and ADaM standards.

• Significant experience supporting oncology clinical trials (hematologic or solid tumors).

• Experience supporting regulatory submissions and preparing submission-ready outputs.

• Excellent communication skills and ability to collaborate cross-functionally.

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-DNP