Senior SDTM Statistical Programmer
Core
Technical lead for clinical data programming, owning SDTM strategies from protocol review to global regulatory submission.
Role type
Senior IC statistical programmer (clinical data)
Builds
SDTM datasets and submission packages for regulatory filings
Domain
Pharmaceutical clinical trials / Regulatory data standards
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, SDTM, CRF
Responsibilities
Lead SDTM strategy from protocol review to submission, perform root cause analysis on data issues, manage CRO and vendor programming activities, mentor junior programmers, interpret Pinnacle 21 validation reports
Seniority
Senior, hands-on IC with leadership responsibilities