About the role
Fractional Vice President, Biometrics Consultant
About the Company
Clinical-stage biotechnology company advancing innovative oncology immunotherapy platforms
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking a Vice President - Biometrics Consultant to lead and oversee biometrics operations, with a focus on innovative oncology-focused clinical trials. The successful candidate will be responsible for ensuring that biometrics activities are in line with clinical evidence generation, regulatory requirements, and strategic priorities. This role involves leading statistical strategy, submission readiness, and data quality initiatives, as well as collaborating with cross-functional teams to shape global development plans and provide data-driven recommendations. The Vice President will also represent the organization in discussions with global health authorities and promote a culture of collaboration and execution excellence within the biometrics team. Applicants for the Vice President - Biometrics Consultant position at the company must have a PhD in statistics, biostatistics, or a related field, with at least 15 years' of experience in the Pharma/Biotech industry. A minimum of 10 years' of leadership experience in clinical trials, particularly with randomized time-to-event data, is required. The ideal candidate will have expertise in oncology, especially pancreatic cancer, and a strong understanding of ICH guidelines and global regulatory requirements. Key skills include strong communication, leadership, and problem-solving abilities in fast-paced environments, as well as experience with NDA/BLA submissions, including eCTD submissions in oncology. The role also demands a proven track record of collaboration with cross-functional teams and the ability to manage competing priorities effectively. Knowledge of HEOR and reimbursement requirements in oncology clinical trials is a plus.
Functions
- ·Data Management/Analytics