Director, Clinical Biostatistics

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Vaxcyte

πŸ’΅ $244k-$262k
πŸ“Remote - United States

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
This job is filled or no longer available