VP, Biometrics

AbCellera•California, CA

About The Position

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.

Requirements

At least 15 years of leadership experience in the biotech or pharmaceutical industry
At least 12 years focused on biostatistics, statistical programming and data management, ideally within both large and small organizations
Extensive expertise with major regulatory submissions such as NDAs or BLAs
Experience representing biometrics in end of phase meetings, advisory committees, or similarly critical regulatory interactions
An advanced degree (Master’s or Ph.D.) in Biostatistics, Statistics, Mathematics, or a related quantitative discipline
An expert level understanding of ICH guidelines, GCP, and CDISC standards
A proven track record attracting, coaching, and leading top talent in biometrics teams
Thrive as a collaborative team member in a highly cross-functional environment, and lead with a curiosity-focused mindset

Responsibilities

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.