VP, Biometrics

AbCellera Biologics Inc.; Sacramento (CA); In loco; USD 350.000 - 600.000; Tempo pieno

Vantaggi offerti da questo lavoro

Equity

Annual bonus

6% 401K contribution

Descrizione del lavoro

AbCellera Biologics Inc. seeks a VP of Biometrics to build and lead biostatistics, statistical programming, and clinical data management functions across their drug development portfolio.

Reporting to the Chief Medical Officer, this strategic role involves overseeing internal teams and external vendors while shaping clinical data strategy from early development through post-approval phases. Responsibilities include shaping study designs and analyses for Phase 1-4 trials, collaborating with

Competenze

• 15+ years leadership experience in biotech or pharmaceutical industry.
• 12+ years focused on biostatistics, statistical programming, and clinical data management.
• Master's or Ph.D. in Biostatistics, Statistics, Mathematics, or related quantitative field.
• Extensive experience with NDA/BLA submissions and regulatory interactions.
• Expert-level knowledge of ICH guidelines, GCP, and CDISC standards.
• Proven track record building and leading high-performing biometrics teams.

Mansioni

• Build and maintain high-performing team across biostatistics, programming, and data management functions.
• Shape clinical data strategy, study designs, and statistical analysis for Phase 1-4 trials.
• Partner with clinical development, regulatory affairs, and cross-functional teams on data-driven decisions.
• Oversee external consultants, vendors, and CROs supporting an expanding pipeline.
• Serve as subject matter expert advising internal stakeholders and Board on quantitative methodologies.

Conoscenze

Leadership

Biostatistics

Clinical data management

Statistical programming

Regulatory submissions

ICH-GCP-CDISC

Vendor management

CRO oversight

Team building

Formazione

Master's or Ph.D. in Biostatistics/Statistics/Mathematics or related field

Descrizione del lavoro

AbCellera seeks a VP of Biometrics to build and lead biostatistics, statistical programming, and clinical data management functions across their drug development portfolio. Reporting to the Chief Medical Officer, this strategic role involves overseeing internal teams and external vendors while shaping clinical data strategy from early development through post-approval phases.

Responsibilities

• Build and maintain high-performing team across biostatistics, programming, and data management functions
• Shape clinical data strategy, study designs, and statistical analysis for Phase 1-4 trials
• Partner with clinical development, regulatory affairs, and cross-functional teams on data-driven decisions
• Oversee external consultants, vendors, and CROs supporting an expanding pipeline
• Serve as subject matter expert advising internal stakeholders and Board on quantitative methodologies

Requirements

• 15+ years leadership experience in biotech or pharmaceutical industry
• 12+ years focused on biostatistics, statistical programming, and clinical data management
• Master's or Ph.D. in Biostatistics, Statistics, Mathematics, or related quantitative field
• Extensive experience with NDA/BLA submissions and regulatory interactions
• Expert-level knowledge of ICH guidelines, GCP, and CDISC standards
• Proven track record building and leading high-performing biometrics teams

Compensation

• Competitive base salary, equity, annual bonus, and 6% non-match 401K contribution