Senior Director of Biostatistics

Job Summary

Leading statistical activities for late-stage vaccine development, the full-time Senior Director of Biostatistics will oversee Phase 2 and Phase 3 clinical trials and pivotal nonhuman primate studies, providing strategic input and ensuring statistical rigor in a fully remote environment.

Key Responsibilities

• 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, ensuring quality and adherence to timelines

Required Qualifications

• 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
• Proficiency in statistical programming (e.g., SAS, R, Python) and working knowledge of CMC statistics