Statistical Programmer II
Core
Develop, validate, and deliver high-quality statistical programming outputs (SDTM, ADaM, TLFs) for regulatory submissions in clinical drug development.
Role type
Senior Statistical Programmer (Clinical Trials)
Builds
Regulatory submission packages (Define.xml, datasets, TLFs) for FDA, PMDA, and EMA
Domain
Pharmaceutical/Biotechnology, Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis
Required skills
SAS programming (Base, STAT, Macro), CDISC standards (SDTM, ADaM), Clinical trial methodologies, Data automation, Regulatory guidelines (E6, E9, 21 CFR Part 11)
Preferred skills
R programming, AI tools for code conversion, Git version control
Technologies
SAS, R, Git, Define.xml, Pinnacle 21
Responsibilities
Develop specifications and SAS programs for SDTM and ADaM datasets; Create and validate Tables, Listings, and Graphs (TLGs); Design and maintain reusable SAS macros; Generate submission-ready datasets; Collaborate with cross-functional teams; Maintain project documentation.
Seniority
Mid-Senior, hands-on IC