Lead Biostatistician

Summary

Join Natera as a Lead Biostatistician to lead biostatistics efforts supporting Natera’s product portfolio of cutting-edge cell-free DNA screening tests. You will leverage your medical device/assay development background and experience in applied statistics to oversee the design, analysis, and reporting of validation experiments supporting Women’s Health and Organ Health portfolio. The ideal candidate will possess strong communication skills and a deep understanding of biostatistics in analytical validation. Responsibilities include study design and analysis, cross-functional collaboration, documentation and reporting, regulatory compliance, and innovation and improvement. The position requires a Ph.D. or Master's degree in a related field, minimum 6 years of relevant experience, and 3 years of experience with statistical analysis software. Natera offers competitive benefits including comprehensive medical, dental, vision, life and disability plans, free testing for employees and their families, fertility care benefits, pregnancy and baby bonding leave, 401k benefits, and commuter benefits.

Requirements

• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field
• Minimum 6 years of relevant experience, with a focus on analytical validation in diagnostics, biotechnology, or related industries
• Minimum of 3 years practical experience with statistical analysis software such as R (preferred), SAS, JMP, etc
• Expert working knowledge of statistical methodology in lab developed tests (LDTs) including an understanding of CLSI 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

• Oversee the design, statistical analysis, and interpretation of analytical validation studies in support of Women’s Health and Organ Health 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 collaborators and stakeholders
• Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA, NYS, and the FDA
• Provide leadership on the application of both common and cutting-edge statistical methods for studies of varying complexity. Directly influence and maintain departmental standards

Preferred Qualifications

Prior experience with NGS and/or genetic assays a plus

Benefits

• Employee benefits include 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
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more