Director of Biostatistics

Summary

Join Natera's oncology team as a Director of Biostatistics and lead a high-performing team in the design, analysis, and interpretation of analytical validation studies for cutting-edge molecular diagnostic tests. You will leverage your expertise to ensure regulatory compliance and data-informed decision-making. This role requires strong leadership and communication skills, a deep understanding of biostatistics in analytical validation, and at least 10 years of relevant experience, including 5 years leading a team. A Ph.D. or Master's degree in a related field is required. Natera offers competitive benefits, including comprehensive medical, dental, vision, life, and disability plans, as well as free testing for employees and their families. The company is committed to fostering a diverse and inclusive workplace.

Requirements

• Minimum 10 years of relevant industry experience, with a focus on analytical validation in diagnostics, biotechnology, or related industries
• At least 5 years leading a team
• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field
• Proven record of hiring, mentoring, and developing a successful, productive team
• Expert working knowledge of statistical methods in diagnostic medicine (e.g., precision, accuracy, LoD/LoQ/LoB, linearity, etc.), including current CLSI and 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
• Exceptional problem-solving skills and attention to detail

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
• 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 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

Preferred Qualifications

Prior experience with NGS, genetics, and/or oncology molecular diagnostic testing

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Generous employee referral program