Senior Director, Biostatistics (Hybrid)

Role Summary

Senior Director, Biostatistics leads and performs highly scientific statistical functions in support of a therapeutic area and new, complex issues. The role drives breakthrough results with strategic and technical contributions, requiring expert biostatistics knowledge and a drug-developer mindset. As a senior leader and people manager, the role involves culture creation, team building, and coaching to direct reports and junior employees across the organization.

Responsibilities

• Defines and implements the technical and strategic direction of the assigned area of responsibility, guiding technological innovation and process improvements aligned to Biostatistics functional/departmental objectives.
• Oversees, manages, and directs multiple key projects, providing both strategic and technical expertise, including clinical trials, observational studies, real world data investigations, or other scientific research.
• Contributes to drug development strategy including clinical development plans and lifecycle management planning documents.
• Develops technical leadership, guides project teams to more meaningful and productive ends, and sets 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 the statistical contributions to external interactions with regulators, payers, review boards, etc.
• Key contributor to Statistical Review Forum (SRF) to enable statistical excellence and Biometrics strategic 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 leading role to departmental working group efforts on various technical and operational issues.
• Oversees the performance of project team members, ensuring proper level of scientific rigor, effective team operation and cross-functional collaboration.
• May contribute to the management of the biostatistics department as a member of the departmental senior leadership team.
• Represents Biostatistics at leadership meetings and senior management reviews.

Qualifications

• 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

Education

• Ph.D. in Statistics or Biostatistics