Manager, Statistical Programming
Core
Leads statistical programming activities for a compound/indication in early pharmaceutical development, guiding a team to create ADaM datasets, TLFs, and regulatory documentation.
Role type
Manager, Statistical Programming
Builds
ADaM datasets, Tables/Lists/Figures, regulatory submission documentation
Domain
Pharmaceutical research and development
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
SAS programming, CDISC standards, drug development process, regulatory filings, team leadership, resource planning, effort estimation
Preferred skills
Standard SAS Macros development, SOP development, mentoring
Technologies
SAS
Responsibilities
Lead statistical programming for early development compounds; Manage team of programmers and resource planning; Ensure quality processes and timely deliverables; Develop SAS programs for ADaM datasets and TLFs; Create documentation for regulatory filings; Develop standard SAS Macros and SOPs; Provide oversight and mentoring to analysts.
Seniority
Manager, hands-on IC with team leadership