Principal Biostatstician
Biogen
July 03, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
About This Role
As a Principal Biostatistician, provide project leadership in Biostatistics for specific products/therapeutic areas. Develop standards across protocols (protocol development, analysis plans, file/report specifications). Review study setup activities (randomization, CRFs, data edits) as lead biostatistician on multiple projects. Perform statistical analyses, interpret results, and prepare clinical study reports including integrated summaries for submissions. Review analyses by other study statisticians to ensure accuracy, consistency, and quality. Address regulatory issues and collaborate with external development partners. Opportunity to act as a CDT statistician under supervision.
What You’ll Do
- Manage moderate/large volumes of complex tasks with minimal supervision across one or more drug programs.
- Assess and adapt solutions for the Biometrics department; resolve technical issues.
- Make study-level decisions; lead and prioritize tasks globally.
- Collaborate with clinical research, regulatory affairs, CROs, Commercial, Worldwide Medical, KOLs, and other disciplines.
- Monitor needs and determine resources with line managers.
- Participate in organization-wide quality and standardization initiatives.
Required Skills
- PhD in Biostatistics/Statistics (or equivalent) + 4 years relevant experience OR MS in Biostatistics/Statistics + 6 years relevant experience.
- Strong statistical principles and clinical trial methodology.
- Ability to provide innovative, practicable technical solutions.
- Medical/biological terminology and clinical trial design knowledge.
- Strong writing and presenting skills.
- SAS programming and detailed statistical software knowledge.
- Working knowledge of regulatory guidelines for statistical analysis.
- Demonstrated leadership and communication skills.
Preferred Skills
- Experience with global-scale task management/decision-making.
- Familiarity with quality and standardization initiatives.
- Ability to interact with KOLs and cross-discipline collaborators.
As a Principal Biostatistician, provide project leadership in Biostatistics for specific products/therapeutic areas. Develop standards across protocols (protocol development, analysis plans, file/report specifications). Review study setup activities (randomization, CRFs, data edits) as lead biostatistician on multiple projects. Perform statistical analyses, interpret results, and prepare clinical study reports including integrated summaries for submissions. Review analyses by other study statisticians to ensure accuracy, consistency, and quality. Address regulatory issues and collaborate with external development partners. Opportunity to act as a CDT statistician under supervision.
What You’ll Do
- Manage moderate/large volumes of complex tasks with minimal supervision across one or more drug programs.
- Assess and adapt solutions for the Biometrics department; resolve technical issues.
- Make study-level decisions; lead and prioritize tasks globally.
- Collaborate with clinical research, regulatory affairs, CROs, Commercial, Worldwide Medical, KOLs, and other disciplines.
- Monitor needs and determine resources with line managers.
- Participate in organization-wide quality and standardization initiatives.
Required Skills
- PhD in Biostatistics/Statistics (or equivalent) + 4 years relevant experience OR MS in Biostatistics/Statistics + 6 years relevant experience.
- Strong statistical principles and clinical trial methodology.
- Ability to provide innovative, practicable technical solutions.
- Medical/biological terminology and clinical trial design knowledge.
- Strong writing and presenting skills.
- SAS programming and detailed statistical software knowledge.
- Working knowledge of regulatory guidelines for statistical analysis.
- Demonstrated leadership and communication skills.
Preferred Skills
- Experience with global-scale task management/decision-making.
- Familiarity with quality and standardization initiatives.
- Ability to interact with KOLs and cross-discipline collaborators.