Principal Biostatistician
Vertex Pharmaceuticals
June 27, 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 Global Medicines Development and Affairs, with some guidance and mentoring on new and complex issues.
Key Duties And Responsibilities:
- Conduct advanced scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations, including design, development, and execution of technical/statistical infrastructure.
- Provide input and technical guidance as a member of clinical trial teams.
- Author study Statistical Analysis Plans (SAPs), including TFL shells; develop cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP).
- Collaborate with statistical programming and other functions to deliver high-quality TFLs timely.
- Contribute to external interactions with regulators, payers, and review boards.
- Develop statistical sections of protocols (sample size estimates and randomization plans).
- Contribute to clinical study reports (CSRs); author/co-author methodological or study-related publications and posters; provide input into programming specifications and review.
- Implement study-level design and analysis methods; participate in Statistical Review Forum (SRF) discussions.
- 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 statistical methods used in drug development.
- Critical thinking and logical problem-solving.
- Excellent written and verbal communication; excels in teams; collaborates well with non-statisticians.
Education And Experience:
- Typically requires 3 years with a Ph.D., or 6 years with a master’s (or equivalent); Ph.D. or master’s in Statistics or Biostatistics.
- The Principal Biostatistician will perform advanced scientific statistical analyses in support of Global Medicines Development and Affairs, with some guidance and mentoring on new and complex issues.
Key Duties And Responsibilities:
- Conduct advanced scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations, including design, development, and execution of technical/statistical infrastructure.
- Provide input and technical guidance as a member of clinical trial teams.
- Author study Statistical Analysis Plans (SAPs), including TFL shells; develop cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP).
- Collaborate with statistical programming and other functions to deliver high-quality TFLs timely.
- Contribute to external interactions with regulators, payers, and review boards.
- Develop statistical sections of protocols (sample size estimates and randomization plans).
- Contribute to clinical study reports (CSRs); author/co-author methodological or study-related publications and posters; provide input into programming specifications and review.
- Implement study-level design and analysis methods; participate in Statistical Review Forum (SRF) discussions.
- 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 statistical methods used in drug development.
- Critical thinking and logical problem-solving.
- Excellent written and verbal communication; excels in teams; collaborates well with non-statisticians.
Education And Experience:
- Typically requires 3 years with a Ph.D., or 6 years with a master’s (or equivalent); Ph.D. or master’s in Statistics or Biostatistics.