Director Biostatistics - late-phase Virology

Role: Director, Biostatistics leading late-phase Virology clinical development programs, focusing on study design, data analysis, interpretation, and regulatory support. Responsibilities: provide statistical leadership, serve as Program Lead if applicable, collaborate with cross-functional teams including Clinical Development, Data Management, Regulatory Affairs, and Medical Writing to ensure high-quality analyses and regulatory documentation. Qualifications: 12+ years with a Bachelor's, 10+ with a Master’s, or 8+ with a PhD; extensive experience in clinical drug development, especially late-phase virology trials, with expertise in statistical methodologies, software, and regulatory processes. Preferred: strong track record in designing and analyzing late-phase trials, supporting regulatory submissions, and working within biopharma development stages such as IND to post-market. High-value specifics: focus on virology (HIV, hepatitis, COVID-19, cancer), late-phase (Phases 3 or beyond), potential Program Lead role, collaborative with clinical and regulatory teams, and leadership in statistical activities. Work setup: flexible, with emphasis on cross-functional collaboration, no explicit location or travel details provided.