VP, Biometrics
About the Role
We are seeking 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 to 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 unique opportunity to establish a world-class biometrics function from the ground up.
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 the organization’s subject matter expert on biometrics and biostatistical trends, advising internal stakeholders and the Board of Directors on quantitative methodologies and 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.
Qualifications
- At least 15 years of leadership experience in the biotech or pharmaceutical industry, with a minimum of 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, and experience representing biometrics in end-of-phase meetings, advisory committees, or similarly critical regulatory interactions
- Advanced degree (Master’s or Ph.D.) in Biostatistics, Statistics, Mathematics, or a related quantitative discipline
- Expert-level understanding of ICH guidelines, GCP, and CDISC standards
- Proven track record of attracting, coaching, and leading top talent in biometrics teams
- Ability to thrive in a collaborative, cross-functional environment with a curiosity-focused mindset
Benefits
- Competitive base salary
- Equity and annual bonus based on individual and company performance
- 6% (non-match) 401K contribution
- CAD $1,500 annual Active Lifestyle Allowance
- Annual vacation and professional development opportunities
- Comprehensive health benefits
About AbCellera
We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in endocrinology, women’s health, immunology, and oncology. Our platform advances antibody drug programs from target to clinic, supporting a pipeline that includes two drug candidates in clinical development, two preclinical candidates in IND-enabling activities, and over 20 active discovery programs. We value tenacious, collaborative, and curious individuals who are passionate about making a meaningful impact through innovative medicines.