Director of Biostatistics (R&D)

This is an exciting opportunity to lead a team of statisticians advancing Natera’s oncology portfolio of cutting-edge molecular tests. As a Director, you will leverage your applied statistics expertise to the design, analysis, and interpretation of analytical validation studies, ensuring compliance with regulatory guidelines and driving data-informed decision-making. The ideal candidate will possess strong leadership and communication skills, and a deep understanding of biostatistics in analytical validation.

• →Team Leadership: Build, mentor, and direct a high-performing biostatistics team, fostering collaboration, and overseeing their technical and professional development.
• →Study Design and Analysis: Oversee the design, statistical analysis, and interpretation of analytical validation studies in support of oncology product development.
• →Cross-Functional Collaboration: Partner with bench scientists, regulatory, and product development teams to integrate statistical expertise into project planning and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary teams.
• →Documentation and Reporting: Prepare high-quality protocols and reports for cross-functional internal and external collaborators and stakeholders.
• →Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA and the FDA. Lead statistical interactions with regulatory agencies.
• →Innovation and Improvement: Provide leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity.
• →Strategic Leadership: Continuously improve the efficiency and efficacy of the team through innovative techniques and strategies. Promote departmental standards for the development and execution of statistical analyses, ensuring alignment with company goals and regulatory requirements.

• Minimum of 8 years of industry experience, including at least 5 years experience in diagnostics. Experience with NGS, genetics, and oncology preferred.
• At least 5 years experience leading a team.
• Master’s degree in statistics, biostatistics, or equivalent, PhD preferred.

• Aptitude for technical leadership and strategic thinking 
• Proven record of leading a successful team
• Expert working knowledge of statistical methodology in diagnostic devices, including FDA guidelines. 
• 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 directly interacting with regulatory agencies such as FDA.

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.