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Staff Biostatistician (Clinical Validation)

Natera· Molecular Biology Informatics & Statistics
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$180.4k - $225.5kFull-timePosted 5d ago

About the role

Staff Biostatistician leading design, analysis, and interpretation of clinical validation studies for regulatory submissions in molecular diagnostics, with emphasis on kidney disease and germline projects.

Responsibilities

  • Strategic Study Design and Analysis: Independently lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic approvals (e.g., CDx, 510(k), PMA, etc.)
  • Regulatory Compliance: Ensure statistical methodologies and analyses meet FDA standards; drive interactions with regulatory authorities.
  • Documentation and Reporting: Prepare SAPs, reports, and presentations for cross-functional and external collaborators.
  • Cross-Functional Leadership: Serve as statistical lead on high-priority projects; collaborate with Clinical Science, Data Management, and Product teams; identify risks and champion solutions.
  • Clinical Research and Beyond: Drive design and execution of research clinical trials, studies, and publications.
  • Stay current with 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 related field
  • At least 8 years of relevant industry experience (preferably in molecular diagnostics/biotech)
  • Regulated environment experience including CDx or IVD submission experience
  • Experience with next-generation sequencing (NGS), genetic, and/or germline-related data
  • Minimum 4 years practical experience with R

Skills

Required:BiostatisticsRegulatory submissionR
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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