Senior Clinical Statistical Programmer (Portfolio Development / Biometrics / Programming)
Core
Lead end-to-end statistical programming for clinical trials from setup to regulatory submission, ensuring data integrity and audit readiness.
Role type
Senior Clinical Statistical Programmer (hands-on IC)
Builds
Submission-ready SDTM and ADaM datasets, tables, figures, listings (TFLs), and integrated analyses
Domain
Pharmaceutical/Biotech clinical research
Deliverable
production ML models | product features | dashboards & analysis
Required skills
SAS (Base/Macro/Stat/Graph), CDISC standards (CDASH, SDTM, ADaM, define.xml), regulatory submission support, CRO management, protocol/SAP interpretation
Preferred skills
R programming, experience with PMDA/NMPA/EMA submissions
Technologies
SAS, R
Responsibilities
Lead programming for assigned trials, design and validate datasets, review CRO deliverables, lead integrated analyses, mentor junior programmers, perform ad hoc regulatory queries
Seniority
Senior, hands-on IC
