Senior Director, Biostatistics (Hybrid)

Role Summary

Senior Director, Biostatistics (Hybrid) leading statistical strategy and team leadership in support of a therapeutic area, guiding technical direction and collaboration across interdisciplinary teams to advance drug development and multicenter studies.

Responsibilities

• Defines and implements the technical and strategic direction of assigned area of responsibility, guiding technological innovation and process improvements aligned to Biostatistics objectives.
• Oversees, manages, and directs multiple key projects, providing strategic and technical expertise across clinical trials, observational studies, real world data investigations, or other research.
• Contributes to drug development strategy including clinical development plans and lifecycle management planning documents.
• Develops technical leadership and guides project teams toward productive outcomes, setting the technical and scientific directions of the projects.
• Oversees the delivery of KRMs, conducts senior review of protocols, CSRs, publications, and statistics-related documents for regulatory interaction, and approves SAPs.
• Contributes or oversees statistical contributions to external interactions with regulators, payers, and review boards.
• Key contributor to Statistical Review Forum to enable statistical excellence and Biometrics input in study design and planning.
• Authors or co-authors methodological or study-related publications and posters.
• Leads or oversees development and implementation of innovative designs and analysis methods.
• Oversees or contributes in a leadership role to departmental working group efforts on technical and operational issues.
• Oversees the performance of project team members, ensuring scientific rigor and cross-functional collaboration.
• May contribute to management of the biostatistics department as a member of the senior leadership team.
• Represents Biostatistics at leadership meetings and senior management reviews.

Education & Experience Required

• Ph.D. in Statistics or Biostatistics.
• Typically requires 12 years of experience with a Ph.D. or the equivalent combination of education and experience.
• Prior people management experience required
• Previous project/process leadership experience required
• NDA/MAA experience and direct dealings with US or European regulators
• Significant expertise with SAS and R statistical software
• Demonstrated expertise in advanced/complex statistical methods used in drug development