The Director will manage CMC planning activities, identifying gaps and implementing cross-functional strategies to support late-stage development and commercial regulatory submissions. They will lead project teams, maintain integrated project plans, and drive decision-making processes across technical operations.
The Statistical Programmer Contractor develops, validates, and maintains SAS programming deliverables to support clinical study analysis and reporting. They collaborate with cross-functional teams to ensure high-quality datasets, tables, listings, and figures while adhering to regulatory and CDISC standards.
The Statistical Programmer Contractor will develop and validate SAS programming deliverables, including SDTM and ADaM datasets, to support clinical study analysis. They will collaborate with cross-functional teams to ensure high-quality, compliant reporting while maintaining audit-ready documentation.
The Senior Director will lead statistical strategy, analysis, and reporting for Phase 3 clinical trials while overseeing regulatory deliverables and cross-functional team collaboration. They are responsible for authoring statistical analysis plans and providing leadership for complex issues including randomized versus treated populations.
