The Statistical Science Director plays a strategic leadership role in the application of statistical science within the pharmaceutical industry. This individual brings extensive experience in statistical methodology, project design, delivery, and interpretation across various stages of product development.
The role requires leading statistical strategy for projects, contributing to regulatory submissions, and influencing internal governance decisions. The Director is recognized externally as an expert in statistical methods and is capable of guiding complex analyses and mentoring junior staff. Strong cross-functional collaboration skills are essential.
Key Responsibilities
- Lead statistical design and strategic planning for product development, including preclinical studies, regulatory strategies, health technology assessments, and commercial applications.
- Oversee statistical content development and ensure high-quality study design, documentation, analysis delivery, interpretation, and regulatory submission.
- Quantify and communicate the benefit-risk profile, value, and uncertainty associated with emerging product data.
- Provide leadership across global teams and direct work performed by internal statisticians and external partners.
- Manage partnerships with CROs to ensure timely, high-quality deliverables.
- Represent the organization in external engagements such as regulatory authority meetings, advisory boards, industry conferences, and payer discussions.
- Stay current with statistical methodologies and promote the adoption of innovative approaches.
- Present statistical strategies and recommendations at internal governance forums, including leadership and decision-making committees.
- Mentor and coach statisticians, contributing to the technical development and training of the statistics function.
Education and Expertise:
- Typically, a PhD in Statistics or a related discipline.
- Recognized expert in statistical methodology, with demonstrated leadership in technical areas.
- External recognition through publications, speaking engagements, or collaborative work.
- Therapeutic area or disease-specific expertise.
- Exposure to business development activities, such as licensing or partnerships.
- Project management capabilities.
- Proficiency in statistical programming languages such as SAS, R, and Python
Qualifications and Experience
- MSc or PhD in Statistics, Mathematics with a strong statistical component, or equivalent.
- Proven ability to lead statistical activities independently across complex projects.
- Exemplary technical and analytical skills, with a record of delivering impactful statistical strategies.