Mantell Associates · 4 days ago
Director of Data Management & Biometrics
United States
Contract
Remote
Director/ExecutiveMantell Associates is partnered with an exciting clinical‑stage biopharmaceutical company, who are searching for a Director of Data Management & Biometrics. This role is responsible for shaping and delivering the strategy for clinical data management, biostatistics, and biometrics functions across global clinical programmes.
EducationPharmaceuticalStaffing Agency
Hiring Manager
George Hebden Lee
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
Qualification
Required
Advanced degree in Statistics, Biostatistics, Computer Science, Life Sciences, or related discipline
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
Preferred
MSc/PhD preferred
Company
Mantell Associates
Mantell Associates is a headhunting firm providing staffing solutions for the medical and life science consulting sectors.
Founded in 2017
51-200 employees
Funding
Current Stage
Growth StageRecent News
Maryland Daily Record
2025-08-12
Company data provided by crunchbase