Statistical Programming Associate Director
Core
Lead statistical programming for clinical trials in oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS, generating regulatory submission-ready outputs.
Role type
Associate Director, Statistical Programming
Builds
CDISC SDTM/ADaM datasets, Define.xml, Reviewer's Guides, and regulatory submission packages for FDA.
Domain
Pharmaceutical clinical trials (oncology, urology, women's health, rare diseases, cell & gene therapies, CNS)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SAS programming (Base, Macros, STAT, Graph, SQL, ODS), CDISC standards (SDTM, ADaM), FDA submission experience, statistical analysis, data management plan review, Pinnacle 21 checks, regulatory guidelines knowledge
Preferred skills
R (Shiny), integrated summaries (ISE/ISS), Clinical Study Reports, coaching/mentoring
Technologies
SAS, R, Pinnacle 21
Responsibilities
Design and validate SAS programs for safety and efficacy analyses; create CDISC SDTM and ADaM files; review Data Management and Validation plans; collaborate with Biostatistics on analysis specifications; mentor team members; act as liaison between programming and project teams; establish monitoring for data transfer quality.
Seniority
Senior, hands-on IC with people management
