Biostatistics Director (Hybrid)
Vertex Pharmaceuticals
3 days ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
- Independently perform highly scientific statistical functions in support of GMDA on new and complex issues, creating alternative approaches as needed. Provide independent strategic and technical contributions. Manage assigned staff with financial and HR responsibilities.
- Hybrid: 2 days/week remote and 3 days/week in Boston Seaport office.
Key Duties and Responsibilities:
- Direct one or more projects (multiple clinical trials, observational studies, RWD) and present to PPRC or other senior review boards.
- Manage direct reports; mentor staff; promote cross-functional collaboration.
- Provide expert input and set technical/scientific directions in cross-functional teams.
- Author SAPs (including TFL shells); develop xFDR plan, KRM, and DDP.
- Lead collaboration with statistical programming and other functions to deliver high-quality TFLs.
- Lead/contribute to interactions with regulators, payers, and review boards.
- Author/co-author methodological or study publications and posters.
- Lead innovative designs/analysis methods and participate in SRF discussions.
- Contribute to departmental technical/operational working groups; handle new highly complex issues.
Knowledge and Skills:
- Prior staff management and project/team oversight.
- SAS and R.
- Advanced/complex statistical methods in drug development.
- Critical thinking, logical problem-solving, strong written/verbal communication.
- Ability to explain complex concepts to non-technical audiences.
- NDA/MAA experience; direct dealings with USA/European regulators.
Education and Experience:
- Ph.D. in Statistics or Biostatistics; typically 10 years with a Ph.D.
- Independently perform highly scientific statistical functions in support of GMDA on new and complex issues, creating alternative approaches as needed. Provide independent strategic and technical contributions. Manage assigned staff with financial and HR responsibilities.
- Hybrid: 2 days/week remote and 3 days/week in Boston Seaport office.
Key Duties and Responsibilities:
- Direct one or more projects (multiple clinical trials, observational studies, RWD) and present to PPRC or other senior review boards.
- Manage direct reports; mentor staff; promote cross-functional collaboration.
- Provide expert input and set technical/scientific directions in cross-functional teams.
- Author SAPs (including TFL shells); develop xFDR plan, KRM, and DDP.
- Lead collaboration with statistical programming and other functions to deliver high-quality TFLs.
- Lead/contribute to interactions with regulators, payers, and review boards.
- Author/co-author methodological or study publications and posters.
- Lead innovative designs/analysis methods and participate in SRF discussions.
- Contribute to departmental technical/operational working groups; handle new highly complex issues.
Knowledge and Skills:
- Prior staff management and project/team oversight.
- SAS and R.
- Advanced/complex statistical methods in drug development.
- Critical thinking, logical problem-solving, strong written/verbal communication.
- Ability to explain complex concepts to non-technical audiences.
- NDA/MAA experience; direct dealings with USA/European regulators.
Education and Experience:
- Ph.D. in Statistics or Biostatistics; typically 10 years with a Ph.D.