Lead/Staff Biostatistician (Analytical Validation)

About the Role

This is an exciting opportunity to independently lead Biostatistics efforts advancing Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics expertise to drive the strategy and execution of complex validation experiments for multiple high-priority projects.

Responsibilities

• Strategic Study Design and Analysis: Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products.
• Cross-Functional Leadership: Serve as the statistical lead on multiple high-priority project teams. Partner with bench scientists, bioinformatics, 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 comprehensive protocols and reports for cross-functional collaborators and stakeholders.
• Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA, NYS, and the FDA.
• Innovation and Improvement: Provide leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity.

Qualifications

• Minimum 5 years (Lead) or 8 years (Staff) of relevant industry experience, with a focus on analytical validation in diagnostics, biotechnology, or related industries.
• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.

Skills

• Expert-level knowledge of statistical methodology in diagnostic medicine, including a deep understanding of CLSI guidelines.
• Exemplary written and verbal communication skills, with a specific talent for presenting to non-technical executive leadership.
• Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds.
• Exceptional problem-solving skills and attention to detail.

About Natera

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.

Benefits

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

Pay

Remote USA: $130,900—$205,000 USD. Actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years and depth of experience, certifications, and specific office location.