Lead Biostatistician (IVD Analytical)

Natera•San Carlos, CA

20h•$144,000 - $180,000

About The Position

This is an opportunity to advance Natera’s regulated product portfolio of molecular diagnostic tests. The Lead Biostatistician oversees the design, analysis, and interpretation of R&D and analytical validation studies for complex biomarkers used in cancer screening, monitoring, and management. The role leads biostatistics efforts supporting CLIA LDT and in vitro diagnostic approvals, performs statistical analyses, documents methods and findings, communicates results to stakeholders, identifies project risks, and mentors junior team members.

Requirements

Master’s degree in biostatistics, statistics, or equivalent with at least 5 years of relevant experience, or PhD in biostatistics, statistics, or equivalent with at least 3 years of relevant experience.
Previous diagnostic experience.
At least 4 years of practical experience with statistical analysis software, including R (required) and SAS or JMP.
Experience designing and executing statistical analyses in a regulated environment.
Expert working knowledge of statistical methodology in diagnostic medicine, including understanding of CLSI guidelines.
Ability and enthusiasm to work on cross-functional teams with members of diverse technical backgrounds.
Strong communication skills, including the ability to explain complex statistical concepts to non-statistical audiences.
Strong track record of producing high-quality written documentation for multiple audiences.

Nice To Haves

Experience negotiating with the FDA.
Experience with next-generation sequencing (NGS), genetics, and/or oncology diagnostics.
Familiarity with DNA methylation.

Responsibilities

Lead biostatistics efforts to design and execute analyses for analytical validation studies supporting CLIA LDT and in vitro diagnostic approvals, including IVDR, 510(k), and PMA.
Perform statistical analyses for validation studies of varying complexity, including sample size, power, agreement, precision, and limit of detection calculations.
Produce presentations and author documentation of analysis plans, methods, results, and interpretation.
Communicate statistical concepts and results to cross-functional internal and external collaborators and stakeholders.
Identify risks, communicate concerns, and champion solutions with interdisciplinary project teams.
Mentor and provide technical supervision to junior team members.