Principal Biostatistician
Vertex Pharmaceuticals
3 months ago
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, with some guidance and mentoring on new and complex issues. Work is resourceful and self-sufficient, creating alternative approaches as needed.
Key Duties and Responsibilities:
- Conduct advanced scientific and operational statistical work for multiple clinical trials, observational studies, or RWD investigations, including designing, developing, and executing technical/statistical infrastructure.
- Provide advanced understanding of modern drug discovery and development processes.
- Represent Biostatistics on clinical trial teams, offering input and technical guidance.
- With minimal guidance, author Statistical Analysis Plans (SAPs) including TFL shells; develop xFDR plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP).
- Collaborate with statistical programming and other functions to deliver TFLs with high quality.
- Contribute to external interactions with regulators, payers, and review boards.
- Develop statistical protocol sections (sample size estimates, randomization plans).
- Contribute to CSRs; author/co-author methodological or study-related publications and posters; provide input to programming specifications and review.
- Implement design and analysis methods at the study level; participate in SRF discussions.
- Contribute to departmental working group efforts on advanced technical/operational issues.
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/verbal communication.
- Strong team skills and ability to collaborate with non-statisticians.
Education and Experience:
- Typically requires 3 years’ experience with a Ph.D. or 6 years’ experience with a master’s degree (or equivalent).
- Ph.D. or master’s degree in Statistics or Biostatistics.
The Principal Biostatistician will perform advanced scientific statistical analyses in support of the Global Medicines Development and Affairs area, with some guidance and mentoring on new and complex issues. Work is resourceful and self-sufficient, creating alternative approaches as needed.
Key Duties and Responsibilities:
- Conduct advanced scientific and operational statistical work for multiple clinical trials, observational studies, or RWD investigations, including designing, developing, and executing technical/statistical infrastructure.
- Provide advanced understanding of modern drug discovery and development processes.
- Represent Biostatistics on clinical trial teams, offering input and technical guidance.
- With minimal guidance, author Statistical Analysis Plans (SAPs) including TFL shells; develop xFDR plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP).
- Collaborate with statistical programming and other functions to deliver TFLs with high quality.
- Contribute to external interactions with regulators, payers, and review boards.
- Develop statistical protocol sections (sample size estimates, randomization plans).
- Contribute to CSRs; author/co-author methodological or study-related publications and posters; provide input to programming specifications and review.
- Implement design and analysis methods at the study level; participate in SRF discussions.
- Contribute to departmental working group efforts on advanced technical/operational issues.
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/verbal communication.
- Strong team skills and ability to collaborate with non-statisticians.
Education and Experience:
- Typically requires 3 years’ experience with a Ph.D. or 6 years’ experience with a master’s degree (or equivalent).
- Ph.D. or master’s degree in Statistics or Biostatistics.