remote
Senior Statistical Programmer - Clinical Data Solution
Software Engineer
Lead statistical programming for clinical trials, designing and validating SAS/R code to generate CDISC‑compliant SDTM and ADaM datasets, TFLs, and reports, while ensuring rigorous quality control and documentation.
About the role
Key Responsibilities
- Review study documents (Protocol, CRF, SAP) to define data and analysis requirements.
- Develop, test, and maintain SAS and/or R programs to create CDISC‑compliant SDTM and ADaM datasets.
- Execute validation and quality control procedures for programs, datasets, and statistical reports, ensuring alignment with study specifications.
- Design and review CDISC SDTM and ADaM mapping specifications and TFLs (Tables, Figures, Listings).
- Identify and document compliance issues in datasets, providing corrective actions and detailed documentation.
Requirements
- Extensive experience in statistical programming for clinical trials using SAS and/or R.
- Deep knowledge of CDISC standards, including SDTM, ADaM, and CDASH.
- Strong analytical skills with meticulous attention to detail and documentation.
- Excellent communication skills for cross‑functional collaboration.
- Ability to work independently in a remote environment.