VP, Biometrics

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. We are looking for a strategic and hands-on VP, Biometrics to lead biometrics across our full portfolio - from IND-enabling studies through registration, launch, and post-approval. Reporting into the Chief Medical Officer, you will build and lead our biostatistics, statistical programming & analysis, and clinical data management functions, balancing hands-on execution with oversight of internal team members and external vendors/contractors. This is a rare opportunity to build a world-class biometrics function from the ground up - if that excites you, we want to hear from you. How you might spend your days Building and maintaining a high performing team across biostatistics, statistical programming & analysis, and clinical data management functions Shaping clinical data strategy, study designs, statistical analysis, reporting, and regulatory interactions for Phase 1 through Phase 4 trials Partnering with clinical development, regulatory affairs, pharmacovigilance, operations, and medical writing functions to drive data-driven business decisions and regulatory approvals Overseeing external consultants, vendors, and contract research organizations (CROs) to support an expanding pipeline Ensuring adherence to global regulatory standards, Good Clinical Practice (GCP), and CDISC guidelines Serving as AbCellera’s subject matter expert on biometrics and biostatistical trends, advising internal stakeholders and the Board of Directors on quantitative methodologies and associated tools in drug development Partnering on interactions with global regulatory agencies and the creation of high quality regulatory documents including study reports, clinical protocols, safety updates, NDA/BLAs, etc. We’d love to hear from you if You have at least 15 years of leadership experience in the biotech or pharmaceutical industry, with at least 12 years focused on biostatistics, statistical programming and data management, ideally within both large and small organizations You have extensive expertise with major regulatory submissions such as NDAs or BLAs, as well as experience representing biometrics in end of phase meetings, advisory committees, or similarly critical regulatory interactions You have an advanced degree (Master’s or Ph.D.) in Biostatistics, Statistics, Mathematics, or a related quantitative discipline You have an expert level understanding of ICH guidelines, GCP, and CDISC standards You have a proven track record attracting, coaching, and leading top talent in biometrics teams You thrive as a collaborative team member in a highly cross-functional environment, and lead with a curiosity-focused mindset W hat we offer In addition to a competitive base salary,…