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 ensure methodologies meet regulatory standards for 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 regulatory agency standards like the FDA.
• 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 to support 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 to explain complex statistical concepts to non-statistical audiences

Nice to have

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

Benefits

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

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 other professionals.