Staff Biostatistician (Analytical Validation)

Natera•San Carlos, CA

22h

About The Position

This is an exciting high-impact 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. The ideal candidate will possess exceptional communication skills and a deep understanding of biostatistics in analytical validation.

Requirements

Minimum 8 years 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.
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

Responsibilities

Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products.
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.
Prepare comprehensive 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.