Senior Director, Biostatistics

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Director, Biostatistics in the United States.

This is a senior scientific leadership role at the intersection of biostatistics, clinical development, and vaccine innovation. You will shape and guide statistical strategy across late-stage (Phase 2 and Phase 3) clinical trials as well as pivotal nonclinical studies supporting advanced vaccine programs. The role has broad cross-functional impact, influencing clinical design, translational science, immunology, and Chemistry, Manufacturing & Controls (CMC). You will act as a key decision-maker in study design, regulatory interactions, and evidence generation strategies that support vaccine licensure. Operating in a highly collaborative and mission-driven environment, you will work closely with internal experts, external partners, and regulatory stakeholders. This is a high-impact leadership position where statistical rigor directly contributes to global public health outcomes.

• Provide strategic leadership on statistical methodology and decision-making across late-stage clinical development and nonclinical programs
• Lead statistical design and analysis for Phase 2/3 clinical trials, including protocol development, SAP creation, and interpretation of results
• Oversee statistical deliverables from CROs and external vendors, ensuring quality, compliance, and timely execution of analyses and reports
• Guide immunobridging strategies and advanced modeling approaches supporting vaccine licensure and translational research objectives
• Support statistical design and evaluation of nonclinical (including NHP) studies aligned with clinical development goals
• Provide expertise in CMC-related statistics, including assay validation, process development, and stability/shelf-life modeling
• Collaborate with cross-functional teams including clinical, immunology, translational science, and regulatory affairs
• Serve as a statistical representative in governance forums, regulatory interactions, and external scientific collaborations
• Mentor and develop internal statisticians while managing external vendors and ensuring alignment across partners
• Drive adoption of advanced statistical methodologies and best practices across the organization

Requirements

• Graduate degree in Biostatistics, Statistics, or a related quantitative field; PhD strongly preferred
• 14+ years of biostatistics experience in pharma, biotech, or vaccine development, including significant leadership in late-phase programs
• Strong expertise in clinical trial design, regulatory submissions, and statistical modeling in vaccines or infectious disease contexts
• Experience with immunobridging approaches and both frequentist and Bayesian statistical modeling methods
• Proficiency in statistical programming languages such as SAS, R, or Python; familiarity with CDISC standards is a plus
• Working knowledge of CMC statistics, assay validation, and nonclinical study design principles
• Proven leadership experience managing teams, vendors, and cross-functional scientific stakeholders
• Strong communication skills with the ability to influence senior leadership and external partners
• Demonstrated ability to translate complex statistical concepts into actionable development strategies
• High level of scientific rigor, strategic thinking, and collaborative mindset

Benefits

• Competitive annual salary range: $200,000 – $240,000 USD
• Comprehensive medical, dental, and vision insurance coverage
• Flexible spending accounts (FSA) for healthcare and dependent care needs
• Employer-paid life and disability insurance
• Flexible vacation policy, sick leave, and paid federal holidays (including year-end winter break)
• Employer-matched 401(k) retirement savings plan
• Opportunity to contribute to global vaccine development with high public health impact
• Remote-friendly work structure (US-based eligibility)
• Supportive, mission-driven environment focused on innovation and collaboration