Principal Statistical Programmer
Core
Senior technical expert developing, validating, and delivering high-quality SAS programming deliverables for clinical trial analysis and regulatory submissions.
Role type
Principal Statistical Programmer (IC)
Builds
CDISC-compliant SDTM/ADaM datasets, TLFs, Define.xml, and reviewer guides for oncology clinical trials.
Domain
Clinical trials / Oncology / Biostatistics
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
SAS programming, CDISC standards (SDTM, ADaM, CDASH), regulatory submission experience, data validation, macro development, cross-functional collaboration
Preferred skills
NDA submission experience, Oncology/Hematology domain knowledge, Pinnacle 21 proficiency
Technologies
SAS, Pinnacle 21, EDC systems, MS Office suite
Responsibilities
Develop programming specifications based on Statistical Analysis Plans; provide hands-on SAS support for key analyses and ad hoc requests; review Data Management Plans and validation documentation; validate CRO-generated datasets using Pinnacle 21; lead technical initiatives for SAS macros and reusable tools; ensure adherence to CDISC and regulatory standards.
Seniority
Principal, hands-on IC with technical leadership