Director, Clinical Biostatistics

Summary

Join Vaxcyte, a clinical-stage vaccine innovation company, as their Director of Clinical Biostatistics! Reporting to the VP of Clinical Development, you will provide statistical support and oversee statistical consultant/CRO services for Vaxcyte's clinical programs. Your responsibilities will encompass protocol design, statistical analysis plan development, data analysis, and report/manuscript drafting. You will also contribute strategically to regulatory submissions and auxiliary studies. This role requires a Ph.D. in Statistics with extensive industry experience in Phase 1-3 vaccine clinical trials. Strong statistical software programming skills (SAS and/or R) and excellent communication skills are essential. The position offers a competitive compensation package, including comprehensive benefits and an equity component.

Requirements

• Ph.D in Statistics, with a minimum of 8 years of industry experience, including 5 years supporting Phase 1-3 vaccine clinical trials
• Advanced knowledge of biostatistics and clinical trial methodology
• Strong knowledge of statistical software programming with SAS and/or R
• Excellent written and oral communication skills to meet the needs of varied audiences
• Integrated understanding of FDA, EMA, ICH, and GCP guidelines
• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals
• Demonstrated ability to manage multiple projects simultaneously, effectively prioritize tasks, and ensure timely completion in a fast-paced environment
• Ability and willingness to travel up to 10-15%
• For remote candidates: ability to work primarily remotely
• Must have legal authorization to work in the United States or Switzerland

Responsibilities

• Provide statistical support and oversee statistical activities contributing to the design of clinical trials, including statistical methodology and determination of sample sizes, estimands, and randomization schemes
• Contribute to and provide expert review of clinical protocols, statistical analysis plans, and clinical study reports
• Provide strategic input to and statistical support for regulatory submissions, including integrated summaries of safety and efficacy, Investigator’s Brochures, annual reports, and responses to regulatory agencies
• Provide oversight of, and maintain effective working relationships with external biostatistics vendors, including monitoring of statistical activities during the conduct of clinical studies
• Work with clinical quality assurance on the development of SOPs to ensure that data analysis and data reporting are in compliance with regulatory requirements, industry standards and best practices
• Stay current on emerging trends, advances, and regulatory guidance related to biostatistics and vaccine development
• Co-author abstracts, posters, presentations, and publications
• Play an active and productive role on multifunctional program and study teams

Preferred Qualifications

Prior interactions with FDA and EMA regulatory agencies are desirable

Benefits

• The compensation package will be competitive and includes comprehensive benefits and an equity component
• Salary Range: $244,000 – $262,000 (SF Bay Area). Salary ranges for non-California locations may vary