Director Biostatistics - late-phase Virology

Role: Lead statistical activities in late-phase Virology clinical development programs, providing expertise in study design, analysis, and interpretation to support regulatory submissions and evidence generation. Responsibilities: serve as Biostatistics Program Lead or collaborate cross-functionally with Clinical Development, Data Management, Regulatory Affairs, and other teams to ensure high-quality statistical contributions; support interactions with health authorities; contribute to study protocols, analysis plans, and regulatory documents; oversee statistical activities across studies, ensuring compliance with GxP standards. Requirements: 12+ years with bachelor's, 10+ years with master’s, or 8+ years with PhD in biostatistics or related fields; extensive experience in clinical drug development, particularly in late-phase trials within virology (e.g., HIV, hepatitis, COVID-19, cancer); proficiency in industry-standard statistical software; strong understanding of regulatory environment and trial methodology; proven leadership in cross-functional settings. Preferred: demonstrated track record in regulatory submissions and managing major clinical studies; ability to communicate complex statistical concepts effectively. High-Value: leadership in virology therapeutic areas; late-phase clinical trials; regulatory interactions; cross-functional team collaboration. WorkSetup: not specified; likely office-based with opportunities for remote work.