Principal Biostatistician
Vertex Pharmaceuticals
August 31, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
General Summary:
- The Principal Biostatistician will perform advanced scientific statistical analyses in support of the Global Medicines Development and Affairs area, working resourcefully and self-sufficiently to create alternative approaches for desired results. Provides some guidance/mentoring on new and complex issues.
Key Duties And Responsibilities:
- Conduct advanced scientific and operational statistical work for multiple clinical trials, observational studies, or RWD investigations, including design, development, and execution of technical/statistical infrastructure.
- Provide advanced understanding of modern drug discovery and development processes.
- Represent Biostatistics on clinical trial teams; provide technical input and guidance.
- Author study Statistical Analysis Plans (SAPs), including table/figure/listing (TFL) shells; develop xFDR plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP).
- Collaborate with statistical programming to ensure timely, high-quality delivery of TFLs.
- Contribute to external interactions with regulators, payers, and review boards.
- Develop statistical protocol sections (sample size estimates, randomization plans).
- Contribute to clinical study reports (CSRs); author/co-author methodological or study publications and posters; support programming specifications and review.
- Implement study-level design/analysis methods; participate in Statistical Review Forum (SRF).
- Contribute to departmental working groups; undertake new/complex issues with minimal guidance.
Knowledge And Skills:
- In-depth experience with SAS and R.
- Demonstrated understanding of advanced statistics used in drug development.
- Critical thinking and logical problem-solving; excellent written/verbal communication.
- Strong team collaboration; collaborates well with non-statisticians.
Education And Experience:
- Ph.D. or master’s degree in Statistics or Biostatistics.
- Typically requires 3 years’ experience (Ph.D.) or 6 years’ experience (master’s), or equivalent combination.
- The Principal Biostatistician will perform advanced scientific statistical analyses in support of the Global Medicines Development and Affairs area, working resourcefully and self-sufficiently to create alternative approaches for desired results. Provides some guidance/mentoring on new and complex issues.
Key Duties And Responsibilities:
- Conduct advanced scientific and operational statistical work for multiple clinical trials, observational studies, or RWD investigations, including design, development, and execution of technical/statistical infrastructure.
- Provide advanced understanding of modern drug discovery and development processes.
- Represent Biostatistics on clinical trial teams; provide technical input and guidance.
- Author study Statistical Analysis Plans (SAPs), including table/figure/listing (TFL) shells; develop xFDR plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP).
- Collaborate with statistical programming to ensure timely, high-quality delivery of TFLs.
- Contribute to external interactions with regulators, payers, and review boards.
- Develop statistical protocol sections (sample size estimates, randomization plans).
- Contribute to clinical study reports (CSRs); author/co-author methodological or study publications and posters; support programming specifications and review.
- Implement study-level design/analysis methods; participate in Statistical Review Forum (SRF).
- Contribute to departmental working groups; undertake new/complex issues with minimal guidance.
Knowledge And Skills:
- In-depth experience with SAS and R.
- Demonstrated understanding of advanced statistics used in drug development.
- Critical thinking and logical problem-solving; excellent written/verbal communication.
- Strong team collaboration; collaborates well with non-statisticians.
Education And Experience:
- Ph.D. or master’s degree in Statistics or Biostatistics.
- Typically requires 3 years’ experience (Ph.D.) or 6 years’ experience (master’s), or equivalent combination.