Vice President, Biometrics and Clinical Analytics

Position Responsibilities

• Serve as the senior biometrics lead across programs, shaping development strategy, trial design, endpoint selection, and risk mitigation.
• Contribute to Phase I/II design (adaptive, Bayesian, dose-finding, and novel endpoints); develop and review statistical sections of protocols, SAPs, and CSR/regulatory documents;
• Support health authority interactions, SRC/DMC/DSMB activities, interim analyses, and independent statistical/unblinding processes—ensuring quality and consistency of biometrics approaches with the CMO.

Organizational Leadership & Team Building

• Establish the standards, processes, and vendor framework that scale the biometrics function.
• Build, hire, and mentor an internal biometrics team over the long term.

Sourcing & Vendor Strategy

• Define and implement Aditum’s biometrics sourcing model—scoping, selecting, contracting, and overseeing CROs, functional service providers, consultants, and specialty vendors.
• Build relationships that provide surge capacity and specialized capabilities while maintaining capital-efficient resourcing.

Data Management, Systems & Quality

• Oversee clinical data management, safety data, and the systems ecosystem (EDC, safety database, data capture, and analytics/reporting platforms).
• Support expedited (E2B) and aggregate safety reporting (e.g., DSURs) with pharmacovigilance.
• Maintain biometrics SOPs and data standards (CDISC/SDTM/ADaM), ensuring data quality and integrity, GCP/ICH (E6, E9) compliance, and audit and inspection readiness across internal and vendor activities.

Analytics, Reporting & Statistical Programming

• Build near-real-time visualizations and operational dashboards from CRO-sourced data to strengthen study oversight.
• Independently generate analyses and maintain analysis datasets for ad hoc internal reporting.
• Oversee the quality of vendor programming outputs and champion reproducible, well-documented practices.

Cross Functional & External Partner Collaboration

• Partner with Clinical, Regulatory, Medical, Translational, CMC, and Business Development teams, and oversee CROs and vendors across biometrics activities.
• Communicate complex statistical concepts clearly to non-statistician stakeholders, adapting depth and language to the audience.