Director, Biostatistics
Syndax Pharmaceuticals
September 02, 2026
Remote
United States
Clinical Research and Development
The Role:
This role provides expertise and guidance in establishing study design and analyses, and instituting best practices for planning, execution, interpretation, and regulatory submission of clinical projects and studies. Provides oversight and guidance to ensure high quality and timely deliverables.
Key Responsibilities:
- Provide strategic input to optimize trial designs in early phase and/or late phase registrational studies
- Collaborate with clinical trial teams to support study conduct
- Provide oversight of external CRO to ensure timely deliverables
- Serve as statistical lead for IND/NDA/MAA and other regulatory interactions; review clinical documents, briefing books, and regulatory submission components (datasets, define files, reviewer’s guides, etc.)
- Perform QC of statistical deliverables, including validation of key results
- Author or oversee statistical analysis plans, statistical protocol sections, and clinical study reports
- Collaborate with Medical Affairs and other departments to support evidence generation and publication
- Stay updated on regulatory requirements and advanced statistical methodology
- Conduct ad hoc analyses as needed
- Lead initiatives within Biostatistics and contribute to cross-functional process improvement
Desired Experience/Education and Personal Attributes:
- Ph.D. or M.S. in Biostatistics (or equivalent) with at least 5 years of pharmaceutical/biotech experience
- Advanced clinical trial design and statistical analysis expertise
- Strategic thinking; strong leadership, communication, and interpersonal skills
- Regulatory requirements and GCP understanding
- Ability to multitask and prioritize
- Strong statistical programming skills using SAS and other statistical software
Benefits/Compensation:
- Anticipated annualized salary range: $235,000 - $260,000
This role provides expertise and guidance in establishing study design and analyses, and instituting best practices for planning, execution, interpretation, and regulatory submission of clinical projects and studies. Provides oversight and guidance to ensure high quality and timely deliverables.
Key Responsibilities:
- Provide strategic input to optimize trial designs in early phase and/or late phase registrational studies
- Collaborate with clinical trial teams to support study conduct
- Provide oversight of external CRO to ensure timely deliverables
- Serve as statistical lead for IND/NDA/MAA and other regulatory interactions; review clinical documents, briefing books, and regulatory submission components (datasets, define files, reviewer’s guides, etc.)
- Perform QC of statistical deliverables, including validation of key results
- Author or oversee statistical analysis plans, statistical protocol sections, and clinical study reports
- Collaborate with Medical Affairs and other departments to support evidence generation and publication
- Stay updated on regulatory requirements and advanced statistical methodology
- Conduct ad hoc analyses as needed
- Lead initiatives within Biostatistics and contribute to cross-functional process improvement
Desired Experience/Education and Personal Attributes:
- Ph.D. or M.S. in Biostatistics (or equivalent) with at least 5 years of pharmaceutical/biotech experience
- Advanced clinical trial design and statistical analysis expertise
- Strategic thinking; strong leadership, communication, and interpersonal skills
- Regulatory requirements and GCP understanding
- Ability to multitask and prioritize
- Strong statistical programming skills using SAS and other statistical software
Benefits/Compensation:
- Anticipated annualized salary range: $235,000 - $260,000