Senior Director, Biostatistics
Zenas BioPharma
August 12, 2026
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Position Summary
The Senior Director of Biostatistics provides statistical leadership and strategic input for one or more clinical development programs. Works with cross-functional teams to align statistical elements with program strategy. Participates in regulatory agency interactions and prepares protocol statistics sections, clinical study reports, and regulatory submission materials. Oversees CRO partners and vendors to ensure project timelines and goals are met.
Key Responsibilities
- Set biostatistical strategy, including contribution to trial design, analysis planning, results interpretation, CSR authoring, regulatory submissions, and publications.
- Manage biostatistics vendors.
- Ensure quality across all statistical aspects of clinical development.
- Represent Biostatistics throughout the clinical development process.
- Serve as primary biostatistics lead for major regulatory interactions; shape briefing books, respond to RFIs, and ensure inspection readiness.
- Lead/Contribute to process improvement and development/implementation of tools to enhance efficiency and quality.
- Mentor/manage junior statisticians.
- Review/author statistical sections of protocols, SAPs, CSRs, regulatory documents, and scientific publications.
- Generate/review randomization and sample size/power estimations; provide specifications for programming implementation (SDTM/ADaM).
- Develop statistical programs for quality/accuracy and analyses (pre-specified or ad hoc).
Qualifications
- PhD in statistics/biostatistics (or related) with 10+ years in clinical research and drug development.
- Strong statistical principles and experience with innovative clinical trial methodology.
- Experience overseeing CROs/vendors/external partners.
- Understanding of ICH GCP and industry standards.
- Experience supporting global clinical trials.
- NDA/BLA submission experience preferred.
- Exceptional communication and problem-solving skills; ability to explain statistical concepts to technical/non-technical stakeholders.
- Cross-functional experience (clinical development, regulatory affairs, medical affairs, commercial).
- Proficiency in SAS and other statistical software.
- Ability to manage people and projects.
- Comfortable in a fast-paced start-up environment; adaptable; flexibility for non-traditional hours as needed.
Benefits/Compensation
- Competitive compensation and benefits package; base salary range: $227,400–$284,256 (actual varies by experience, education, skills, performance, and/or location).
The Senior Director of Biostatistics provides statistical leadership and strategic input for one or more clinical development programs. Works with cross-functional teams to align statistical elements with program strategy. Participates in regulatory agency interactions and prepares protocol statistics sections, clinical study reports, and regulatory submission materials. Oversees CRO partners and vendors to ensure project timelines and goals are met.
Key Responsibilities
- Set biostatistical strategy, including contribution to trial design, analysis planning, results interpretation, CSR authoring, regulatory submissions, and publications.
- Manage biostatistics vendors.
- Ensure quality across all statistical aspects of clinical development.
- Represent Biostatistics throughout the clinical development process.
- Serve as primary biostatistics lead for major regulatory interactions; shape briefing books, respond to RFIs, and ensure inspection readiness.
- Lead/Contribute to process improvement and development/implementation of tools to enhance efficiency and quality.
- Mentor/manage junior statisticians.
- Review/author statistical sections of protocols, SAPs, CSRs, regulatory documents, and scientific publications.
- Generate/review randomization and sample size/power estimations; provide specifications for programming implementation (SDTM/ADaM).
- Develop statistical programs for quality/accuracy and analyses (pre-specified or ad hoc).
Qualifications
- PhD in statistics/biostatistics (or related) with 10+ years in clinical research and drug development.
- Strong statistical principles and experience with innovative clinical trial methodology.
- Experience overseeing CROs/vendors/external partners.
- Understanding of ICH GCP and industry standards.
- Experience supporting global clinical trials.
- NDA/BLA submission experience preferred.
- Exceptional communication and problem-solving skills; ability to explain statistical concepts to technical/non-technical stakeholders.
- Cross-functional experience (clinical development, regulatory affairs, medical affairs, commercial).
- Proficiency in SAS and other statistical software.
- Ability to manage people and projects.
- Comfortable in a fast-paced start-up environment; adaptable; flexibility for non-traditional hours as needed.
Benefits/Compensation
- Competitive compensation and benefits package; base salary range: $227,400–$284,256 (actual varies by experience, education, skills, performance, and/or location).