Vice President, Biometrics

The Company is in search of a Vice President, Biometrics to play a pivotal role in the establishment and leadership of the biometrics function as the organization prepares to enter the clinic. This is a unique opportunity to be part of a team that is dedicated to the development of novel therapies with the potential to make a significant impact on the treatment of cancer. The successful candidate will be responsible for building the biometrics function from the ground up, including defining the strategy, operating model, and standards. They will serve as the statistical lead for the first-in-human study, providing expertise in early-phase design, and ensuring scientific rigor in all aspects of the development strategy. The role also involves close collaboration with cross-functional teams, overseeing CROs and vendors, and scaling the function as the clinical portfolio expands. Applicants for the Vice President, Biometrics position at the company should hold a Ph.D. in statistics, biostatistics, or a related quantitative field, with at least 15 years of experience in clinical development statistics within the biopharmaceutical industry. A strong background in oncology, including hands-on experience with early-phase oncology studies and familiarity with oncology endpoints, is essential. The ideal candidate will have a proven track record in leading statistical contributions to regulatory submissions, a deep understanding of ICH guidelines, and proficiency in SAS and/or R. The role requires a collaborative leader with excellent communication skills, the ability to influence without hierarchy, and a dedication to scientific rigor. Experience in cell or gene therapy, particularly in the context of oncology, and a background in supporting expedited regulatory pathways, are highly valued.