Principal Statistical Programmer
Core
Lead statistical programming for clinical trials, ensuring data accuracy and compliance for regulatory submissions in oncology, hematology, immunology, and cardiovascular disease.
Role type
Principal Statistical Programmer (IC with strategic influence)
Builds
Submission-ready clinical data packages and regulatory filings
Domain
Biopharma / Clinical Data Management
Required skills
SAS programming, CDISC standards (SDTM/ADaM), clinical data pipeline management, regulatory submission expertise, cross-functional collaboration, process improvement
Preferred skills
Team leadership, mentoring technical professionals, strategic programming advice
Technologies
SAS, CDISC, eDC systems, electronic submission platforms
Responsibilities
Design and implement technical solutions for complex clinical data; lead and support electronic submissions for regulatory filings; review statistical analysis plans and shape programming strategy; mentor and develop other technical professionals; identify and resolve process inefficiencies
Seniority
Principal, hands-on IC with strategic influence