Director of Biostatistics (R&D)

Natera • San Carlos, CA

6h • $213,800 - $267,300

About The Position

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.

Requirements

• Minimum of 8 years of industry experience, including at least 5 years experience in diagnostics.
• At least 5 years experience leading a team.
• Master’s degree in statistics, biostatistics, or equivalent.
• 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.

Nice To Haves

• Experience with NGS, genetics, and oncology preferred.
• PhD preferred.

Responsibilities

• Build, mentor, and direct a high-performing biostatistics team, fostering collaboration, and overseeing their technical and professional development.
• Oversee the design, statistical analysis, and interpretation of analytical validation studies in support of oncology product development.
• 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.
• Prepare high-quality protocols and reports for cross-functional internal and external collaborators and stakeholders.
• 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.
• Provide leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity.
• 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.

Benefits

• Annual performance incentive bonus
• Long-term equity awards
• Comprehensive health benefits (medical, dental, vision)
• 401(k) with company match
• Generous paid time off and company holidays
• Additional wellness and work-life benefits
• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents.
• Free testing for employees and their immediate families
• Fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Director