Biostatistical Programming Manager
Core
Lead statistical programming activities for clinical studies, serving as Study Lead Programmer (SLP) to manage end-to-end delivery, strategy, and compliance for one or more studies.
Role type
Senior IC Biostatistical Programming Manager (Study Lead Programmer)
Builds
Clinical study deliverables including SDTM/ADaM datasets for regulatory submissions
Domain
Biotechnology / Clinical Development / Statistical Programming
Required skills
Statistical programming (SAS, R), CDISC standards (SDTM, ADaM), project management, team leadership, data quality compliance, clinical trial processes
Preferred skills
MSc in statistics/biostatistics, open-source tools (Python), automation platforms, regulatory submission experience
Technologies
SAS, R, Python, CDISC standards
Responsibilities
Set programming strategy and ensure quality/compliance; lead and manage statistical programmers; create/maintain programming specifications; coordinate cross-functional study start-up activities; perform hands-on programming for challenging deliverables; manage technical aspects like computing environments; provide training and guidance to team members.
Seniority
Senior, hands-on IC with leadership responsibilities