Director, Biostatistics

About This Role

Directing biostatistics for late-phase Virology clinical development programs is at the heart of this role, encompassing the design, analysis, interpretation, and communication of clinical trial results. As a potential Biostatistics Program Lead, you will collaborate closely with cross-functional teams to ensure high-quality statistical contributions that support clinical development, regulatory submissions, and evidence generation. This position suits a candidate with strong technical expertise, sound scientific judgment, and effective communication skills to advance innovative therapies for patients.

Responsibilities

• Provide statistical leadership for late-phase Virology clinical development programs, contributing to study design, analysis planning, data interpretation, and evidence generation to support development and regulatory objectives
• Serve as the Biostatistics Program Lead for Virology programs or major studies, representing the Biostatistics function on cross-functional teams and supporting interactions with Health Authorities as needed
• Partner effectively with Statistical Programming, Clinical Development, Data Management, Clinical Operations, Global Patient Safety, Regulatory Affairs, Medical Writing, and Project Management to ensure timely delivery of high-quality analyses, regulatory submissions, and clinical study reports
• Apply statistical expertise and regulatory knowledge to support study design, protocol development, statistical analyses, interpretation of clinical trial results, and preparation of regulatory documentation
• Provide leadership for statistical activities across assigned clinical studies, ensuring high-quality study design, analysis planning, data review, and regulatory documentation through collaboration with internal teams, external partners, and CROs

Requirements

• 12+ Years with bachelor's degree
• 10+ Years with master’s degree
• 8 years with PhD
• Demonstrated hands-on experience in clinical drug development, including design, analysis, and interpretation of late-phase clinical trials and support of regulatory submissions
• Strong expertise in biostatistics and clinical trial methodology, with proficiency in industry-standard statistical software and application of appropriate statistical methods to support study objectives and decision-making
• Good understanding of the biopharmaceutical development process and regulatory environment, with the ability to integrate scientific and regulatory considerations into statistical recommendations
• Proven ability to work effectively in cross-functional teams and communicate statistical concepts to a variety of stakeholders, including clinicians, regulatory colleagues, and senior management
• Experience leading statistical activities for clinical development programs or major studies, managing multiple priorities, and delivering high-quality results within timelines