Associate Director of Biostatistics

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Natera

πŸ’΅ $154k-$192k
πŸ“Remote - United States

Summary

Join Natera as a Lead Biostatistician and lead biostatistics efforts for the company's oncology portfolio. You will oversee the design, analysis, and reporting of validation experiments for multiple high-priority projects. Responsibilities include study design and analysis, cross-functional collaboration, documentation and reporting, regulatory compliance, and driving innovation. A minimum of 6 years of relevant industry experience and a Ph.D. or Master's degree in a related field are required. The ideal candidate will possess strong communication skills and a deep understanding of biostatistics in analytical validation. Natera offers competitive benefits, including comprehensive medical, dental, vision, life and disability plans, free testing for employees and their families, fertility care benefits, and more.

Requirements

  • Minimum 6 years of relevant industry experience, with a focus on analytical validation in diagnostics, biotechnology, or related industries
  • Ph.D. or Master's degree in Biostatistics, Statistics, or a related field

Responsibilities

  • Oversee the design, statistical analysis, and interpretation of analytical validation studies in support of oncology product development
  • Partner with bench scientists, regulatory, and product development teams to integrate statistical expertise into project planning and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary teams
  • Prepare high-quality protocols and reports for cross-functional collaborators and stakeholders
  • Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA, NYS, and the FDA
  • Provide leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity

Preferred Qualifications

  • Prior experience with NGS, genetics, and/or oncology testing
  • Aptitude for technical leadership and strategic thinking
  • Proven record of leading a successful team
  • Expert working knowledge of statistical methodology in diagnostic medicine, including CLSI and FDA guidelines
  • Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
  • Strong track record of producing high quality written documentation for multiple audiences

Benefits

  • Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
  • Natera employees and their immediate families receive free testing in addition to fertility care benefits
  • Pregnancy and baby bonding leave
  • 401k benefits
  • Commuter benefits

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