Executive Director, Biostatistics Scientific Advisory

Overview

In this role you will provide statistical consulting and strategic advice across drug, device, and diagnostic development, including regulatory interactions. You will lead innovative study designs and contribute to proposals and client discussions from a Biostatistics perspective. As a trusted expert, you will shape development programs and guide complex statistical strategy in collaboration with cross-functional teams. You will represent Parexel in key regulatory meetings and help advance high-quality clinical research. This opportunity offers impact at scale, working with clients to accelerate therapies to patients while shaping the direction of statistical science in clinical development.

Responsibilities

• Provide statistical consulting and guidance throughout the clinical development process.
• Design and optimize clinical development programs and protocols; prepare submissions across indications.
• Interact with clients and regulatory authorities, including representation at regulatory meetings.
• Lead or contribute to client meetings on innovative study designs, analysis concepts, and interpretation of results.
• Provide technical leadership on advanced statistical designs and complex issues in trials.
• Support new business through proposals, bids, and cross-functional collaboration.
• Participate in bid defense meetings and assist in client marketing and thought leadership.
• Coordinate department activities and contribute to regulatory compliance and cross-department relationships.
• Support development of biostatisticians in partnership with senior management.

Key requirements

• PhD in Statistics or MS in Statistics (or related discipline).
• Significant pharmaceutical industry experience with broad development knowledge.
• Direct consulting experience.
• Experience designing and executing drug, device, or diagnostic development programs.
• Direct interactions with regulatory agencies (FDA, EMEA, etc.) and experience with regulatory submissions and negotiations.
• Understanding of regulatory guidance and submission processes; experience with Advisory Committee preparation.
• Experience with conference presentations and manuscript writing.

• Excellent organizational, communication, negotiation, problem-solving, analytical, and consulting skills
• Technical leadership and ability to work in a high-performing team
• Collaborative cross-functional communication of complex concepts to clients and regulators
• Expertise in innovative trial designs
• Protocol and development program optimization
• Regulatory submission strategies and interactions

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