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Staff Biostatistician (Clinical Validation)

Natera· Molecular Biology Informatics & Statistics
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Hybrid (US Remote)$164k - $205kfull-timePosted 5d ago

About the role

Staff Biostatistician focused on design, analysis, and interpretation of clinical validation studies for regulated diagnostic products (CDx, 510(k), PMA) in the kidney disease and germline space, with regulatory interaction and cross-functional leadership.

Responsibilities

  • Independently lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic approvals (e.g., CDx, 510(k), PMA, etc.)
  • Ensure statistical methodologies and analyses meet FDA standards and drive statistical interactions with regulatory authorities
  • Prepare comprehensive SAPs, reports, and presentations for cross-functional and external collaborators
  • Serve as the statistical lead on high-priority project teams; partner with Clinical Science, Data Management, and Product teams to integrate statistical expertise
  • Drive design and execution of clinical trials, studies, and publications
  • Stay current with advancements in Biostatistics and clinical validation methodology; implement innovative approaches for regulatory submissions
  • Mentor and provide technical supervision to junior team members

Qualifications

  • Ph.D. or Master's degree in Biostatistics, Statistics, or a related field
  • At least 8 years of relevant industry experience, preferably within molecular diagnostics, biotechnology, or related fields
  • Demonstrated experience in regulated environments, including previous CDx or IVD submission experience
  • Experience with next-generation sequencing (NGS), genetic, and/or germline-related data
  • Minimum of 4 years practical experience with R statistical analysis software

Skills

Required:Clinical validation study designStatistical analysis for regulatory submissionsR

Benefits

  • Competitive Benefits - comprehensive medical, dental, vision, life and disability plans for eligible employees and dependents
  • Free testing for employees and their immediate families plus fertility care benefits
  • Pregnancy and baby bonding leave, 401k benefits, commuter benefits
  • Generous employee referral program
Last updated Oct 22, 2026. Interested? Apply on the company site.

About Natera

A global leader in cfDNA testing

Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care.

oncologywomen's healthorgan healthcell-free DNA
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