Note: The job is a remote job and is open to candidates in USA. ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical companies. They are seeking a Principal Data Scientist Consultant with strong experience in R and clinical programming to develop and maintain datasets, support clinical trial deliverables, and ensure regulatory compliance.
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
Skills
- 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
- 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
Company Overview
Company H1B Sponsorship