Principal Statistical Programmer
Core
End-to-end statistical programming for clinical studies from setup through regulatory submission, ensuring CDISC compliance and high-quality deliverables.
Role type
Principal Statistical Programmer (Clinical Development)
Builds
SDTM datasets, ADaM datasets, Tables/Lists/Figures (TLFs), and regulatory submission packages (define.xml, reviewer's guides)
Domain
Clinical Research / Life Sciences / Regulatory Submissions
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
SDTM dataset development, ADaM dataset development, TLF programming, CDISC standards expertise, regulatory submission requirements knowledge, SAS Macros, complex study management
Preferred skills
Technical leadership, mentoring programmers, risk identification, process improvement
Technologies
SAS (Base and Advanced), SAS Macros
Responsibilities
Lead development and validation of SDTM, ADaM, and TLF datasets; ensure compliance with CDISC and regulatory guidelines; support FDA/EMA submissions; provide technical guidance to the programming team; review and approve deliverables for accuracy and quality; collaborate with Biostatistics, Data Management, and Regulatory teams.
Seniority
Principal, hands-on IC with leadership responsibilities