Staff Biostatistician (Clinical Validation)

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), reports, and presentations for cross-functional and external collaborators and stakeholders.
• Cross-Functional Leadership: Serve as the statistical lead on high-