Associate Director, SAS Programming
Core
Lead statistical programming for assigned compounds, ensuring CDISC conformance, submission readiness, and quality of deliverables produced internally or by partners.
Role type
Senior IC statistical programming lead (SAS)
Builds
Submission-ready clinical data packages (SDTM, ADaM, TLF) and integrated datasets for safety/efficacy summaries
Domain
Clinical trials / Biopharmaceuticals
Required skills
Expert-level SAS programming (Base, STAT, Macro, ODS, GRAPH, SQL), CDISC standards (SDTM, ADaM, define.xml), clinical trial data knowledge, regulatory requirements (GCP, ICH, 21 CFR Part 11, FDA/EMA/PMDA), resource planning, vendor oversight
Preferred skills
R programming, Pinnacle 21 tooling, NDA/BLA/MAA submission experience, generative AI tools for programming
Technologies
SAS, R, Pinnacle 21, CDISC standards
Responsibilities
Set compound programming strategy and standards, develop and validate SDTM/ADaM/TLF programs, manage CRO/FSP resources and quality, design integrated datasets, support regulatory submissions and audits, deliver ad hoc analyses for leadership
Seniority
Senior, hands-on IC with strategic oversight