Job Description
The Director, Biostatistics will provide statistical leadership for late-phase Virology clinical development programs, supporting the design, analysis, interpretation, and communication of clinical trial results. As a potential Biostatistics Program Lead, this individual will collaborate closely with cross-functional teams to ensure the delivery of high-quality statistical contributions that support clinical development, regulatory submissions, and evidence generation. The successful candidate will combine strong technical expertise, sound scientific judgment, and effective communication skills to help advance innovative therapies for patients.
Key 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.
- Opportunity to 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.
Basic Qualifications:
- 12+ Years with bachelor's degree
- 10+ Years with master’s degree
- 8 years with PhD
Preferred Qualifications:
- 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.
People Leader Accountabilities:
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
