Head of Statistics

Watton Hall is partnered with a market leading CRO based in Europe.

As the Head of Statistics, you will be responsible for leading the statistical function across all phases of clinical trials, ensuring high-quality statistical methodologies and deliverables. You will oversee a talented team of statisticians, collaborate with key stakeholders, and provide strategic guidance on statistical approaches to support regulatory submissions and client projects. Your role will be critical in shaping the statistical direction of our clinical trials and ensuring the delivery of accurate and actionable insights.

Key Responsibilities:

• Lead, mentor, and manage a team of statisticians and data scientists, fostering a collaborative and high-performance culture.
• Provide strategic statistical input into trial designs, including sample size determination, randomization methods, and analysis plans for clinical trials.
• Guide statistical strategies for regulatory submissions, including preparation for clinical trial reports and statistical sections of IND, NDA, and other regulatory filings.
• Ensure the integrity and accuracy of statistical analyses and results throughout the life cycle of clinical trials.
• Serve as the primary point of contact for statistical matters with clients, ensuring clear and timely communication regarding study results, statistical methodologies, and timelines.
• Ensure compliance with Good Clinical Practice (GCP) and other regulatory requirements in all statistical work.
• Lead efforts to adopt and implement cutting-edge statistical tools and technologies.

Requirements:

• Ph.D. or Masters in Statistics, Biostatistics, Mathematics, or a related field.
• Extensive experience in the CRO industry with leadership/ managerial responsibilities.
• Proven track record of leading teams and managing multiple clinical trials and statistical deliverables simultaneously.
• In-depth knowledge of statistical software (e.g., SAS, R, or similar).
• Strong understanding of regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
• Exceptional leadership, communication, and interpersonal skills.