Statistical Science Director

• 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.

• Demonstrate deep knowledge of technical and regulatory requirements in pharmaceutical and healthcare settings.
• Lead the implementation of novel statistical methodologies into applied practice.
• Contribute to or lead regulatory interactions and submissions from a statistical perspective.
• Establish and maintain strong collaborative relationships through excellent communication.
• Achieve national or international recognition as a statistical expert through speaking engagements, publications, and external collaborations.
• Serve in a technical leadership capacity, guiding the direction and delivery of work across teams.

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.

• 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.

Desirable Attributes:

• 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.