Senior SDTM Statistical Programmer
Core
Technical lead for clinical data programming, owning SDTM strategies from protocol review to global regulatory submission.
Role type
Senior SDTM Statistical Programmer (Technical Lead)
Builds
SDTM datasets, validation reports, and regulatory submission packages for global filings.
Domain
Pharmaceutical clinical trials and regulatory submissions
Required skills
SAS programming (Base, Stat, Graph), CDISC/SDTM standards, clinical development lifecycle knowledge, cross-functional collaboration, vendor/CRO management
Preferred skills
SDTM automation, metadata-driven processes, Agentic AI workflows
Technologies
SAS, Pinnacle 21, CRF systems
Responsibilities
Shape SDTM strategies from protocol review to submission, perform root cause analysis and data integration, provide guidance and quality oversight to team members, manage CRO and vendor programming activities, interpret validation reports for regulatory filings
Seniority
Senior, hands-on IC with leadership responsibilities
