Senior Manager, Statistical Programming
Core
Lead statistical programming for clinical studies, ensuring CDISC-compliant data packages and submission readiness for oncology trials.
Role type
Senior Manager, Statistical Programming
Builds
CDISC-compliant SDTM, ADaM datasets, TLFs, Define.xml, and reviewer guides for regulatory submissions
Domain
Clinical trials / Oncology / Biostatistics
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
SAS programming, CDISC standards (SDTM, ADaM, CDASH), regulatory submission experience, CRO management, macro development, data validation
Preferred skills
NDA submission experience, Oncology/Hematology domain knowledge
Technologies
SAS, Pinnacle 21, EDC systems
Responsibilities
Lead programming for 1-2 clinical studies; develop and validate CDISC-compliant datasets; provide hands-on SAS support; manage timelines and cross-functional dependencies; review CRO outputs; develop reusable SAS macros; mentor junior programmers
Seniority
Senior Manager, hands-on IC with team oversight