Clincal R programmer/ Principal Data Scientist Consultant (R with CDISC)
ClinChoice · United States
- Hybrid
- Contract
- $120,000 / year
- United States
Tailored resume — keyword-matched to this role.
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Job highlights
- Develop R-based SDTM/ADaM datasets following CDISC.
- Generate Tables, Listings, Figures using R/SAS.
- Collaborate with cross-functional clinical teams.
- Ensure regulatory compliance for submissions.
- Work for a client with CRO security.
About the role
Job Overview
ClinChoice is seeking a Principal Data Scientist Consultant with strong experience in R and a solid background in clinical programming to join one of our clients. This role offers the unique benefit of working directly for a single sponsor while retaining the security and career opportunities of a global CRO. It's the best of both worlds, providing a dynamic and supportive work environment focused on accelerating the development of innovative drugs and devices.
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.
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. With over 28 years of proven high-quality delivery, we employ over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our mission is to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. We value our employees, providing continuous training and development to ensure they are highly qualified and equipped to manage processes with a consistent methodology. ClinChoice is an equal opportunity employer, committed to diversity, inclusivity, and fostering a strength from varied backgrounds.
The Application Process
Upon submitting your CV, you will receive an acknowledgement. Candidates meeting the requirements will be invited for an initial phone interview. Due to application volume, we cannot reply to every applicant individually.
Key skills/competency
- Clinical R Programmer
- Principal Data Scientist
- R Programming
- CDISC Standards
- SDTM Datasets
- ADaM Datasets
- SAS Programming
- Clinical Trial Data
- Regulatory Submissions
- Data Analysis & Reporting
Skills & topics
- R programming
- Clinical Programmer
- Data Scientist
- CDISC
- SDTM
- ADaM
- SAS
- Clinical Trials
- Biostatistics
- Regulatory Submissions
- Data Analysis
- Life Sciences
- CRO
- Pharmaceutical
- Biotechnology
How to get hired
- Tailor your resume: Highlight your R programming, CDISC standards, and clinical trial data experience. Quantify achievements in dataset development and regulatory compliance.
- Showcase technical skills: Emphasize your proficiency in R for SDTM/ADaM, SAS knowledge, and familiarity with clinical programming toolkits.
- Demonstrate collaboration: Provide examples of working effectively with biostatisticians, data managers, and clinical teams on trial deliverables.
- Prepare for interviews: Be ready to discuss your experience with CDISC standards, regulatory expectations, and problem-solving in clinical programming.
- Understand ClinChoice's mission: Research their commitment to accelerating drug development and their global reach as a CRO.
Technical preparation
Master R for SDTM/ADaM dataset creation.,Practice reproducible R script writing.,Review CDISC SDTM and ADaM standards.,Refresh SAS programming fundamentals.
Behavioral questions
Describe a complex clinical data challenge.,How do you ensure reproducible code?,Discuss collaboration with statistical teams.,Explain your QC process for deliverables.
Frequently asked questions
- What specific R packages are most relevant for this Principal Data Scientist role at ClinChoice?
- For this Principal Data Scientist role at ClinChoice, demonstrating experience with R packages crucial for clinical programming is key. This includes familiarity with the 'tidyverse' for data manipulation, 'haven' for reading SAS files, and specific clinical data packages like 'admiral' and 'tidyCDISC' from the 'pharmaverse' ecosystem. Proficiency in these tools will be highly valued as they are often used for developing SDTM and ADaM datasets.
- How important is SAS programming knowledge for this R-focused Clinical R Programmer position at ClinChoice?
- While the role emphasizes R programming for clinical data analysis and SDTM/ADaM dataset development, working knowledge of SAS is still important. The job description mentions utilizing SAS for legacy studies or where SAS support is required, indicating that a foundational understanding and ability to work within SAS environments is beneficial for this Clinical R Programmer position at ClinChoice.
- What does ClinChoice mean by 'working directly for a single sponsor' in this Principal Data Scientist role?
- This means you will be embedded with a specific client (the 'sponsor') while remaining an employee of ClinChoice. This arrangement allows you to focus on a particular company's projects, providing a deep dive into their development pipeline, while still benefiting from ClinChoice's global CRO structure, resources, and career development opportunities.
- What are the primary CDISC standards I should be familiar with for the Clinical R Programmer role at ClinChoice?
- For this Clinical R Programmer role at ClinChoice, the primary CDISC standards you must be familiar with are SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model). These are the core standards for organizing and structuring clinical trial data for submission to regulatory agencies like the FDA and EMA.
- How does ClinChoice ensure quality and regulatory compliance in its data science and programming roles?
- ClinChoice emphasizes quality and regulatory compliance through rigorous QC checks, data reconciliation processes, and adherence to regulatory expectations (e.g., FDA, EMA). The role involves ensuring that all deliverables meet these standards, contributing to programming workflows, documentation, and potentially GxP validation and version control best practices.