General Summary:
- Independently perform highly scientific statistical functions supporting Global Medicines Development and Affairs (GMDA) on new and complex issues.
- Provide independent strategic and technical contributions; complete work resourcefully and self-sufficiently, creating alternative approaches as needed.
- Serve as a people manager with financial accountability and HR responsibilities for assigned staff.
- Hybrid role: 2 days/week remote and 3 days/week in Boston Seaport office.
Key Duties and Responsibilities:
- Direct one or more projects across multiple clinical trials, observational studies, or RWD investigations; present to PPRC or other senior review boards.
- Manage direct reports (performance, development); mentor and promote cross-functional collaboration.
- Provide expert strategic input and set technical/scientific directions within cross-functional teams.
- Author SAPs (including TFL shells); develop xFDR plan, KRM, and DDP.
- Lead collaboration with statistical programming to deliver high-quality TFLs.
- Lead or contribute to external interactions with regulators, payers, and review boards.
- Author/co-author publications and posters.
- Lead innovative design/analysis methods; participate in SRF discussions.
- Contribute to departmental working groups; handle new and highly complex issues.
Knowledge and Skills:
- Prior staff management; project management/oversight.
- SAS and R; advanced/complex drug development statistics.
- Critical thinking/problem-solving; strong written/verbal communication.
- Collaborate with non-statisticians; explain complex concepts.
- NDA/MAA experience; direct experience with USA/European regulators.
Education and Experience:
- Ph.D. in Statistics or Biostatistics (typically 10 years with a Ph.D.).