Director of Data Management & Biometrics

Director of Data Management & Biometrics

Mantell Associates is partnered with an exciting clinical‑stage biopharmaceutical company, who are searching for a Director of Data Management & Biometrics. This is a senior leadership role, responsible for shaping and delivering the strategy for clinical data management, biostatistics, and biometrics functions across global clinical programmes.

This role provides a rare opportunity to lead and scale a world‑class data organisation that ensures rigorous, compliant and insightful delivery of clinical data to support regulatory submissions and scientific decision‑making.

Director of Data Management & Biometrics – Responsibilities:

• Lead and develop the Data Management & Biometrics function, including Clinical Data Management (CDM), Biostatistics, Statistical Programming, and medical coding standards
• Own the design and delivery of data strategies that ensure high data quality, integrity and compliance throughout clinical development
• Oversee development and implementation of data standards, CRF design, data flow plans, and database build/validation strategies
• Partner with Clinical Operations, Safety, Regulatory, and IT to implement leading‑edge technologies (e.g., EDC, eCOA, RTSM, CDISC standards)
• Drive statistical analysis planning, statistical methods, and interpretation of complex clinical datasets
• Ensure delivery of high‑quality, timely outputs for interim looks, IDMC reporting, regulatory submissions, and final study reports
• Represent Data Management & Biometrics in leadership forums, influencing cross‑functional decision‑making and resource prioritisation.

Director of Data Management & Biometrics – Requirements:

• Advanced degree in Statistics, Biostatistics, Computer Science, Life Sciences, or related discipline; MSc/PhD preferred
• Significant leadership experience in clinical data management and biostatistics within a biopharmaceutical or CRO environment
• Proven track record of building and managing high‑performing biometrics teams through multiple phases of clinical development
• Deep knowledge of CDISC standards (SDTM, ADaM), regulatory expectations, and EDC/CTMS environments
• Demonstrated experience with advanced analytics, data standards, and clinical database design
• Exceptional communicator with the ability to collaborate across functions, present to senior leadership, and engage external partners.

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.

EEO/Disclaimer

We are an equal opportunity employer. Referrals increase your chances of interviewing at Mantell Associates by 2x.

Note: This listing includes the role title, responsibilities, requirements, and contact information as provided in the original posting. Other job listings and extraneous content originally in the description have been removed to improve clarity and compliance with formatting guidelines.