Staff Biostatistician (Clinical Validation)

The role

You will lead the design, analysis, and interpretation of clinical validation studies for kidney disease and germline projects. You will drive statistical strategy and regulatory interactions to support in vitro diagnostic approvals.

What you will do

• Lead the design, analysis, and interpretation of clinical validation studies for IVD approvals.
• Ensure statistical methodologies meet FDA and other regulatory agency standards.
• Drive statistical interactions with regulatory authorities.
• Prepare statistical analysis protocols, reports, and presentations.
• Serve as the statistical lead on high-priority project teams.
• Partner with Clinical Science, Data Management, and Product teams.
• Drive design and execution of research clinical trials, studies, and publications.
• Implement innovative approaches for diagnostic product development.
• Mentor and provide technical supervision to junior team members.

Required qualifications

• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field
• At least 8 years of relevant industry experience
• Demonstrated experience in regulated environments, including previous CDx or IVD submission experience
• Experience with next-generation sequencing (NGS), genetic, and/or germline-related data
• Minimum of 4 years practical experience with R statistical analysis software
• Expert working knowledge of statistical methodology in diagnostic medicine
• Understanding of FDA guidelines
• Previous experience interacting with regulatory bodies such as the FDA
• Ability to work on cross-functional teams
• Track record of producing high quality written documentation
• Experience in design and analyses of clinical validation studies
• Strong communication skills

Nice to have

• Prior experience with germline assay development
• Prior experience with kidney disease

Benefits

• Annual performance incentive bonus
• Long-term equity awards
• Comprehensive health benefits (medical, dental, vision)
• 401(k) with company match
• Generous paid time off and company holidays
• Life and disability plans
• Free testing for employees and immediate families
• Fertility care benefits
• Pregnancy and baby bonding leave
• Commuter benefits

About the company

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The team consists of statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals.