Principal Data Scientist Consultant with experience in R and CDISC (Remote)
RemoteUnited States
United StatesRemoteFull TimeSenior LevelDoctorate Or Professional DegreeHealthcare TechLarge
Full TimeSenior LevelDoctorate Or Professional DegreeLargeHealthcare Tech
Job Summary
Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards. Write efficient, reproducible R scripts for clinical data analysis and reporting while supporting TLF generation in R or SAS. Collaborate with statisticians and data managers to understand programming requirements, perform QC checks, and reconcile data issues to ensure deliverables meet FDA and EMA regulatory expectations. Contribute to programming workflows, documentation, and version control best practices, including automation initiatives and R-based pipeline development. Utilize SAS for legacy studies where 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
Desired 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
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