Description:
The Senior Director, Biostatistics will lead and perform highly scientific statistical functions in support of a company Therapeutic Area, as well as new and complex innovative issues. The Senior Director drives breakthrough results with strategic and technical contributions, while possessing an excellent knowledge of Biostatistics with a drug developer mindset. As a senior leader and people manager within the organization, they will play a crucial role in 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 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, and including clinical trials, observational studies, real world data (RWD) 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/or productive ends. Sets
the technical and scientific directions of the project(s).
- 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.
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