VP, Biometrics

The role

You will lead biometrics across the full portfolio from IND-enabling studies through post-approval. You will build and lead biostatistics, statistical programming & analysis, and clinical data management functions.

What you will do

• 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
• Overseeing external consultants, vendors, and contract research organizations (CROs)
• 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
• Partnering on interactions with global regulatory agencies and the creation of high quality regulatory documents

Required qualifications

• 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
• 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
• 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 attracting, coaching, and leading top talent in biometrics teams

Nice to have

• Experience within both large and small organizations

Benefits

• Equity
• Annual bonus dependent on individual and company performance
• 6% (non-match) 401K contribution
• CAD $1,500 annual Active Lifestyle Allowance
• Annual vacation
• Professional development opportunities
• Comprehensive health benefits

Before you apply

• Refer to Job ID 23399 in your cover letter
• Only those selected for an interview will be contacted

About the company

AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology.