Associate Director, Statistical Programming
Core
Lead statistical programming for early-phase clinical programs, establishing scalable practices and delivering regulatory submission artifacts.
Role type
Senior IC statistical programmer with management responsibilities
Builds
Regulatory submission deliverables (DSUR, IB, annotated CRFs, define documents) and scalable programming infrastructure
Domain
Biopharmaceutical clinical development (neurological, psychiatric, endocrine, immunological disorders)
Required skills
SAS programming (Base, Stat, Macro, Graph), CDISC standards (SDTM, ADaM), regulatory submission compliance, team leadership, vendor management, database management
Preferred skills
Early-phase study design expertise, PK/PD knowledge, healthy volunteer study experience
Technologies
SAS, Microsoft Office Suite, relational databases
Responsibilities
Provide strategic leadership for statistical programming across clinical programs; develop efficient approaches for analysis and regulatory submissions; lead hiring, training, and oversight of in-house and contract programmers; validate vendor programming activities; create and validate e-submission requirements; serve as primary programmer for agency reporting deliverables
Seniority
Senior, hands-on IC with management duties
