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.

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.

Clinical R Programmer Consultant

Key skills