Mantell Associates
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.