Biostatistician; Clinical Validation) US Remote

• 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

• Education: Ph.D. or Master's 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

• 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.

US Remote

$164,000 - $205,000 USD

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families…