Lead Biostatistician (IVD Analytical)

Natera

20h • $130,900 - $163,600 • Remote

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, including IVDR, 510(k), and PMA submissions. It also produces analysis plans and study documentation, communicates statistical findings to collaborators and stakeholders, identifies project risks and solutions, and mentors junior team members.

Requirements

• Master’s degree in biostatistics, statistics, or equivalent with at least 5 years of relevant experience, or a 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 for working 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.
• Prior experience with next-generation sequencing (NGS), genetics, and/or oncology diagnostics.
• Familiarity with DNA methylation.

Responsibilities

• Lead biostatistics efforts in designing and executing analyses for analytical validation studies supporting CLIA LDT and in vitro diagnostic approvals.
• Perform statistical analyses for validation studies, including sample size, power, agreement, precision, and limit-of-detection calculations.
• Prepare presentations and author documentation of analysis plans, methods, results, and interpretation.
• Communicate statistical concepts and results to 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.

Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.
• Free testing for employees and their immediate families.
• Fertility care benefits.
• Pregnancy and baby bonding leave.
• 401(k) benefits.
• Commuter benefits.
• Employee referral program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior