Statistical Science Director

Job Description: Statistical Science Director

Experience: 12-20 Years

Therapy: Any Therapy

This is an IC role with supporting team members

• Key Points: Looking for Candidate who as an IC can handle Project and Strategy including Making Key Decision Independently
• Has extensive experience handling Global Project as an IC
• Must be Technically very strong

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.

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

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

Project Leadership:

• 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.

Technical and Methodological Leadership:

• 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

Essential – Project Focus:

• 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.