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 (Senior IC with strategic influence)
Builds
Submission-ready clinical data packages for global health authorities
Domain
Biopharma / Clinical Data Management / Regulatory Affairs
Required skills
SAS programming, CDISC standards (SDTM/ADaM), clinical data pipeline management, regulatory submission expertise, cross-functional collaboration, process improvement, team mentorship
Preferred skills
Team leadership experience, strategic advisory to stakeholders
Technologies
SAS, CDISC, SDTM, ADaM, eDC systems, TFLs, electronic submission platforms
Responsibilities
Design and implement technical solutions for complex clinical data, lead and support electronic regulatory filings, review statistical analysis plans, shape programming strategy, mentor technical professionals, identify and resolve process inefficiencies
Seniority
Principal, hands-on IC with strategic influence and team leadership potential