Senior Director, Biostatistics

Position Title: Senior Director, Biostatistics

Reports to: Vice President, Translational R&D

Location: Remote Worker, US Only

Why Sabin:
 

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative, and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization. Sabin staff, management and the Board of Trustees are committed to ensuring that fairness, integrity, and opportunity remain at the core of how we operate.

Position Summary:  

We are seeking an accomplished and strategic Senior Director of Biostatistics to lead and oversee all statistical activities supporting Phase 2 and Phase 3 clinical trials and pivotal nonhuman primate (NHP) studies in cutting-edge vaccine development programs. This role will provide statistical leadership across a range of functional areas, including human and clinical immunology assay development, nonhuman primate (NHP) nonclinical studies, and Chemistry, Manufacturing & Controls (CMC). 

The ideal candidate will be an experienced biostatistician with knowledge of modern approaches to clinical development, translational sciences, and CMC. The individual will drive innovative and scientifically rigorous approaches in the design of experiments (DOEs), statistical model development, and data interpretation across the organization.

Key Responsibilities:

The Senior Director of Biostatistics will provide strategic leadership for statistical activities supporting late-stage vaccine development programs, including Phase 2/3 clinical trials and pivotal nonclinical studies. The role will ensure statistical rigor across clinical development, translational sciences, and CMC, while serving as a key representative for biostatistics in internal governance, external collaborations, and regulatory interactions. Key responsibilities are fulfilled through combined vendor management and in-house execution and include:

• Provide strategic input to senior leadership on statistical implications of development strategies across functional areas
• Lead statistical strategy for Phase 2/3 clinical trials, including study design, SAP development, and data interpretation.
• Oversee statistical deliverables from CROs and external partners, including interim analyses, study reports, and regulatory submissions, ensuring quality and adherence to timelines.
• Partner with clinical and translational teams to support immunobridging models and innovative approaches to vaccine licensure.
• Guide statistical design and analysis of pivotal nonclinical studies, ensuring alignment with clinical objectives.
• Provide statistical expertise in process development, analytical validation, and stability/shelf-life modeling.
• Manage relationships with external vendors, key opinion leaders, and regulatory agencies to ensure effective stakeholder engagement and alignment.
• Mentor and develop internal statisticians and other team members; manage external vendors and resources.
• Stay current with statistical methodology and regulatory standards and use expertise to drive adoption of innovative statistical methodologies and best practices across the organization.

• Minimum of a graduate degree in Biostatistics, Statistics, or a related field; doctoral degree strongly preferred
• 14+ years of biostatistics experience in pharma/biotech, with substantial leadership in late-phase clinical development
• Expertise in clinical trial design, regulatory submissions, and statistical modeling in vaccines or infectious diseases.
• Experience with immunobridging, logistical regression methods, and Bayesian or frequentist modeling
• Working knowledge of CMC statistics, assay validation, and nonclinical study design.
• Proficiency in statistical programming (e.g., SAS, R, Python); experience with CDISC standards is a plus
• Proven leadership, communication, and cross-functional collaboration skills

Other: 

• Subject to a criminal background investigation 
• Request for three professional references 
• Verification of education/degrees 

Sabin’s philosophy is to ensure fair, unbiased, equitable, competitive compensation and benefits. Using benchmarking and salary survey data, the annual salary for this position ranges from $200,000 - $240,000. The exact compensation may vary based on skills, experience, training, and certifications/degree. As a grant-funded organization, Sabin actively seeks funding for existing and new programs.

Sabin provides a comprehensive benefits package that includes medical, dental, and vision coverage, as well as flexible spending accounts. Eligible employees receive flexible vacation and sick leave, along with employer-paid life and disability insurance. The organization observes 11 federal holidays and an end-of-year winter break. Sabin also offers an employer-matching 401(k) plan.

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.