Biostatistical Programming Manager
Core
Lead statistical programming activities for clinical studies, serving as Study Lead Programmer to manage teams and ensure compliance with regulatory standards.
Role type
Senior IC Biostatistical Programming Manager
Builds
Clinical study deliverables including SDTM and ADaM datasets for regulatory submissions
Domain
Biotechnology / Clinical Trials
Required skills
Statistical programming, CDISC SDTM/ADaM standards, SAS (including SAS/STAT), Project management, Team leadership, Data quality compliance
Preferred skills
R, Python, Automation platforms, Regulatory submission experience
Technologies
SAS, SDTM, ADaM
Responsibilities
Set programming strategy and manage timelines for study deliverables, Lead and manage statistical programmers, Create and maintain programming specifications, Perform hands-on statistical programming for challenging deliverables, Coordinate data issue reporting and resolution, Provide technical guidance and training to the team
Seniority
Senior, hands-on IC
