Manager, Statistical Programming
Core
Strategic leadership of statistical programming activities for new pharmaceutical product development in early stages.
Role type
Manager, Statistical Programming
Builds
ADaM data sets, Tables, Listings, Figures, and regulatory documentation for drug development.
Domain
Pharmaceutical / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
SAS programming, CDISC standards, drug development process, regulatory filings, team leadership, resource planning, effort estimation, standard SAS macro development
Preferred skills
MS in Statistics/CS, BS with 10+ years exp, cross-functional communication
Technologies
SAS
Responsibilities
Lead statistical programming for compounds/indications, manage team and resource planning, ensure quality and consistency, develop SAS programs for ADaM and TLFs, create regulatory documentation, mentor staff, develop standard macros and SOPs
Seniority
Manager, hands-on IC with team leadership