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Active4d ago

Staff Biostatistician (Clinical Validation)

Natera·📍 San Carlos, California, United States

Employment

Full-Time

Work mode

On-site

Experience

SENIOR LEVEL

Salary

$180.4K – $225.5K/yr

Role overview

Job description

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics, IVD, and Clinical Research expertise to drive the strategy, design, analysis, and interpretation of clinical validation studies for kidney disease and other high-priority germline projects. PRIMARY 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 the standards set by regulatory agencies such as FDA. Drive statistical interactions with regulatory authorities. Documentation and Reporting : Prepare comprehensive statistical analysis protocols (SAPs), r

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What they are looking for

Skills & requirements

Qualification

Education : Ph.D. or Master's degree in Biostatistics, Statistics, or a related field

Department · Molecular Biology Informatics & Statistics

Hiring company

Natera

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.

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