Lead Biostatistician (IVD Clinical)

PRIMARY RESPONSIBILITIES

• Design and review statistical methodology in protocols and statistical analysis plans
• Lead execution of statistical analyses according to plans and protocols, as well as exploratory or ad-hoc analyses
• Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation
• Effectively convey statistical concepts and results to cross-functional internal and external collaborators and stakeholders
• Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams
• Mentor and provide technical supervision to junior team members
• Perform other duties as assigned

  QUALIFICATIONS

  • Master’s degree in biostatistics, statistics, or equivalent with 5+ years of relevant experience, or PhD in biostatistics, statistics, or equivalent with 3+ years of relevant experience
  • At least 3 years practical experience designing and executing statistical analyses in a regulated environment and clinical trials for regulatory submissions
  • Minimum of 4 years practical experience with statistical analysis software such as R (preferred), SAS, or JMP
  • Previous diagnostic experience preferred

  KNOWLEDGE, SKILLS, AND ABILITIES

  • Expert knowledge of probability theory and statistics including the ability to evaluate and produce novel methods and applications
  • Familiarity with typical approaches, best practices, and regulatory standards in clinical trial design
  • Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
  • Strong communication skills, with the ability to explain complex statistical concepts to non-statistical audiences
  • Track record of producing high quality written documentation for multiple audiences
  • Prior experience with next-generation sequencing (NGS), genetics, and/or oncology testing a plus
  • Previous experience interacting with regulatory bodies such as the FDA preferred

    Career Opportunities

    • Compensation Range: $144,000 - $180,000 USD
    • Total Rewards: Annual performance incentive bonus, long-term equity awards, comprehensive health benefits, 401k with company match, generous paid time off and company holidays, additional wellness and work-life benefits

    About Natera

    • Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health.
    • The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.
    • We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives.

    Equal Opportunity Employer

    • Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives.

    Contact Information

    • For more information, visit www.natera.com/notice-of-data-collection-california-residents/.
    • To apply for this job, please visit https://www.natera.com/notice-of-data-collection-california-residents/.