Vice President, Biometrics

Vice President, Biometrics About the Company Thriving biotech company developing innovative treatments for muscle-related diseases IndustryBiotechnology TypePublic Company Founded1998 Employees201-500 Specialties heart failureamyotrophic lateral sclerosisspinal muscular atrophyhypertrophic cardiomyopathyand hypertrophic cardiomyopathy Business Classifications B2BSAAS About the Role The Company is seeking a VP of Biometrics to lead the strategic and tactical advancement of the biometrics department. This executive role is pivotal in managing all biometrics functions, including biostatistics, data management, statistical programming, and clinical systems. The successful candidate will be responsible for defining and executing the department's vision, establishing its organizational structure, and overseeing all biometrics activities to support clinical development projects. This includes the development of innovative study designs, ensuring compliance with regulatory guidelines, and providing biometrics input on major documents for regulatory filings. The VP will also guide the application of epidemiologic methods to strengthen submission evidence and support drug development, as well as interact with health authorities to ensure regulatory compliance. Applicants for the VP of Biometrics position at the company should have a Ph.D. in statistics or a related field with at least 15 years' of experience in the pharmaceutical industry, or a Master's degree with a minimum of 20 years' experience. The role requires expert knowledge of ICH and other regulatory development guidelines, experience in recruiting and developing team members, and a deep understanding of mathematical and statistical principles. Proficiency in at least one statistical analysis software, preferably SAS, is essential. The ideal candidate will have experience in the clinical development of a wide range of therapeutic areas, excellent communication and presentation skills, and a proven track record of leadership in a team environment. Knowledge of good biometrics procedures and experience in interacting with regulatory authorities is also desired. Hiring Manager TitleSVP of Development Operations Travel PercentLess than 10% Functions Medical Care/Hospital Administration

Created: 2025-01-30