Director of Biostatistics (R&D)

Das ist der Job

Lead statistical interactions with regulatory agencies.

Darum lohnt es sich

This is an exciting opportunity to lead a team of statisticians advancing Natera’s oncology portfolio of cutting-edge molecular tests. Primary Responsibilities Team Leadership : Build, mentor, and direct a high‑performing biostatistics team, fostering collaboration, and overseeing their technical and professional 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.

Strategic Leadership : Continuously improve the efficiency and efficacy of the team through innovative techniques and strategies. At least 5 years experience leading a team.

Knowledge, Skills, and Abilities 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.

Remote USA $193,600—$242,000 USD Competitive Benefits Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, employees and their immediate families receive free testing in addition to fertility care benefits.

Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

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. Study Design and Analysis : Oversee the design, statistical analysis, and interpretation of analytical validation studies in support of oncology product development.

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.

Innovation and Improvement : Provide leadership on the application of both common and cutting‑edge statistical methods for studies of varying complexity. Promote departmental standards for the development and execution of statistical analyses, ensuring alignment with company goals and regulatory requirements.

Qualifications Minimum of 8 years of industry experience, including at least 5 years in diagnostics. Experience with NGS, genetics, and oncology preferred. Master’s degree in statistics, biostatistics, or equivalent; PhD preferred. Natera also offers a generous employee referral program! Natera is proud to be an Equal Opportunity Employer.

We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status.

We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. #J-18808-Ljbffr