Interim Vice President, Biometrics Consultant

Interim Vice President, Biometrics Consultant

About the Company

Clinical-stage biotechnology company advancing innovative immunotherapy platforms targeting oncology, particularly solid tumors.

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 global health authorities and stakeholders to drive strategic statistical initiatives in a dynamic environment. Key responsibilities for the Vice President - Biometrics Consultant include overseeing biostatistics and statistical programming activities, leading the development of departmental processes, and mentoring junior staff. The role also requires providing strategic and technical leadership for innovative statistical methods, ensuring the quality of biometrics deliverables, and managing external vendors for outsourced biometrics activities. The ideal candidate will have a PhD in statistics, biostatistics, or a related field, with at least 15 years of experience in the Pharma/Biotech industry, and a strong background in oncology, particularly pancreatic cancer. Expertise in ICH guidelines, global regulatory requirements, and experience with NDA/BLA submissions, including eCTD submissions in oncology, are essential. The role demands strong communication, leadership, and problem-solving skills, as well as the ability to collaborate with cross-functional teams and manage competing priorities effectively.

Functions

• Data Management/Analytics