Senior Director, Biostatistics
Zenas BioPharma
July 01, 2026
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Position Summary
Senior Director of Biostatistics providing 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; prepares protocol statistic sections, clinical study reports, and regulatory submission materials; provides oversight to CRO partners and vendors to meet timelines and goals.
Key Responsibilities
- Set biostatistical strategy (clinical development plans, trial design input, analysis planning, results presentation/interpretation, CSR authoring, regulatory submissions, publications).
- Manage biostatistics vendors.
- Ensure quality across all statistical aspects of clinical development.
- Foster scientific rigor and cross-functional collaboration.
- Represent Biostatistics throughout the clinical development process.
- Lead for major regulatory interactions (briefing books, RFIs, inspection readiness).
- Lead/contribute to process improvement and tool/process development to enhance efficiency and quality.
- Mentor/manage junior statisticians.
- Review/author statistical analysis sections of protocols, SAPs, CSRs, regulatory documents, and publications.
- Develop/review randomization and sample size/power; key statistical specs for programming (SDTM/ADaM, analysis datasets, TLFs).
- Develop statistical programs for quality/accuracy and ad-hoc or pre-specified analyses.
Qualifications
- PhD in statistics/biostatistics (or related) and 10+ years in clinical research and drug development.
- Experience implementing statistical principles and innovative clinical trial methodology.
- Experience working with/overseeing CROs, vendors, and external partners.
- Understanding of ICH GCP; knowledge of industry standards.
- Prior experience supporting global clinical trials.
- NDA/BLA submission experience preferred.
- Exceptional interpersonal and problem-solving skills.
- Strong oral/written communication; 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 tools.
- Ability to manage people and projects.
- Comfortable in fast-paced start-up environment with evolving processes; flexible/adaptable.
- Ability to work non-traditional hours as needed for international time zones.
Benefits / Compensation
- Competitive compensation and benefits package.
- Base salary range: $227,400–$284,256; total rewards also include annual performance bonus, equity, full range of benefits, and other incentives.
Senior Director of Biostatistics providing 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; prepares protocol statistic sections, clinical study reports, and regulatory submission materials; provides oversight to CRO partners and vendors to meet timelines and goals.
Key Responsibilities
- Set biostatistical strategy (clinical development plans, trial design input, analysis planning, results presentation/interpretation, CSR authoring, regulatory submissions, publications).
- Manage biostatistics vendors.
- Ensure quality across all statistical aspects of clinical development.
- Foster scientific rigor and cross-functional collaboration.
- Represent Biostatistics throughout the clinical development process.
- Lead for major regulatory interactions (briefing books, RFIs, inspection readiness).
- Lead/contribute to process improvement and tool/process development to enhance efficiency and quality.
- Mentor/manage junior statisticians.
- Review/author statistical analysis sections of protocols, SAPs, CSRs, regulatory documents, and publications.
- Develop/review randomization and sample size/power; key statistical specs for programming (SDTM/ADaM, analysis datasets, TLFs).
- Develop statistical programs for quality/accuracy and ad-hoc or pre-specified analyses.
Qualifications
- PhD in statistics/biostatistics (or related) and 10+ years in clinical research and drug development.
- Experience implementing statistical principles and innovative clinical trial methodology.
- Experience working with/overseeing CROs, vendors, and external partners.
- Understanding of ICH GCP; knowledge of industry standards.
- Prior experience supporting global clinical trials.
- NDA/BLA submission experience preferred.
- Exceptional interpersonal and problem-solving skills.
- Strong oral/written communication; 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 tools.
- Ability to manage people and projects.
- Comfortable in fast-paced start-up environment with evolving processes; flexible/adaptable.
- Ability to work non-traditional hours as needed for international time zones.
Benefits / Compensation
- Competitive compensation and benefits package.
- Base salary range: $227,400–$284,256; total rewards also include annual performance bonus, equity, full range of benefits, and other incentives.