Staff Biostatistician (Clinical Validation)

Location: US Remote

Department: Molecular Biology Informatics & Statistics

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-priority project teams. Partner with Clinical Science, Data Management, and Product teams to integrate statistical expertise into project planning and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams
• Clinical Research and Beyond: Drive design and execution of high-impact research clinical trials, studies, and publications that push the development of our world-class product portfolio
• Stay current with advancements in Biostatistics and clinical validation methodology, implementing innovative approaches to support diagnostic product development and regulatory submissions
• Mentor and provide technical supervision to junior team members

QUALIFICATIONS: 

• Education: Ph.D. or Masters degree in Biostatistics, Statistics, or a related field
• Experience: 
• 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

KNOWLEDGE, SKILLS, AND ABILITIES: 

• Expert working knowledge of statistical methodology in diagnostic medicine, including an understanding of FDA guidelines 
• Previous experience interacting with regulatory bodies such as the FDA.
• Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
• Strong track record of producing high quality written documentation for multiple audiences 
• Prior experience with germline assay development preferred
• Prior experience with kidney disease desired
• Experience in design and analyses of clinical validation studies
• Strong communication skills, with the ability to explain complex statistical concepts to non-statistical audiences.
• Attention to detail and a commitment to delivering high-quality work under tight deadlines.