CMC Statistics Lead - Remote Vaccine Development

Vaxcyte, Inc; San Carlos (CA); On-site; USD 170,000 - 198,000; Full time

Job summary

Vaxcyte, Inc is seeking a talented Associate Director, CMC Statistician to join the Global Analytical organization. This pivotal role involves leading statistical efforts in specification setting and justification, collaborating across various teams including Manufacturing, Quality, and Regulatory Affairs to ensure robust statistical strategies.

The ideal candidate should possess extensive knowledge in CMC statistics, 10+ years of relevant industry experience, and the ability to convey complex statistical concepts clearly to diverse stakeholders. This remote position offers a competitive salary range of $170,000 - $198,000 and comprehensive benefits.

Qualifications

• 10+ years of experience in pharmaceutical/biotech industry.
• Hands-on experience in CMC statistics and specification setting.
• Strong understanding of regulatory expectations for biologics.

Responsibilities

• Serve as the CMC statistical lead for specification-setting strategy.
• Develop statistical strategies for drug substances and product specifications.
• Design and execute statistical analyses for late-stage development.

Skills

CMC statistics

Statistical software (R, SAS, JMP, Python, Minitab)

Analytical development

Statistical methods (regression, ANOVA, DOE)

Education

MS or PhD in Statistics, Biostatistics, Mathematics

Job description

Vaxcyte, Inc is seeking a talented Associate Director, CMC Statistician to join the Global Analytical organization. This pivotal role involves leading statistical efforts in specification setting and justification, collaborating across various teams including Manufacturing, Quality, and Regulatory Affairs to ensure robust statistical strategies.

The ideal candidate should possess extensive knowledge in CMC statistics, 10+ years of relevant industry experience, and the ability to convey complex statistical concepts clearly to diverse stakeholders. This remote position offers a competitive salary range of $170,000 - $198,000 and comprehensive benefits.