Staff Biostatistician

Summary

Join Natera as a Staff Biostatistician and contribute to the advancement of our regulated molecular diagnostic tests. You will lead biostatistical efforts in designing and executing studies for in vitro diagnostic approvals. Responsibilities include leading interactions with regulatory authorities, statistical analyses, and mentoring junior team members. This role requires a Ph.D. or Master's in Biostatistics and at least 8 years of relevant experience, including expertise in regulated environments and NGS data. Preferred qualifications include experience with complex biomarkers and design of clinical studies. Natera offers competitive benefits, including comprehensive medical, dental, vision, life and disability plans, free testing for employees and their families, fertility care benefits, and more.

Requirements

• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field
• At least 8 years of experience in Biostatistics, preferably within molecular diagnostics, biotechnology, or related fields
• Demonstrated experience in regulated environments
• Experience evaluating next-generation sequencing (NGS), genetic, and/or oncology-related data
• Minimum of 4 years practical experience with statistical analysis software such as R (preferred), SAS, or JMP
• Expert working knowledge of statistical methodology in diagnostic medicine, including an understanding of CLSI and FDA guidelines
• Previous experience interacting with regulatory bodies such as the FDA
• Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
• Strong track record of producing high quality written documentation for multiple audiences

Responsibilities

• Lead Biostatistics efforts designing and executing development, analytical, and clinical studies to support in vitro diagnostic approvals (e.g., IVDR, 510(k), PMA, etc.)
• Lead interactions with regulatory authorities
• Lead statistical calculations and analyses for studies of varying complexity
• Promote statistical and regulatory best practices
• Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation
• Effectively convey statistical concepts and results to cross-functional internal and external collaborators and stakeholders
• Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams
• Stay current with advancements in Biostatistics and analytical/clinical validation methodology, implementing innovative approaches to support product development and regulatory submissions
• Mentor and provide technical supervision to junior team members
• Perform other duties as assigned

Preferred Qualifications

• Prior experience with complex biomarkers (e.g., TMB, MSI, Methylation) preferred
• Experience in design of both non-clinical (analytical) and clinical studies desired
• Strong communication skills, with the ability to explain complex statistical concepts to non-statistical audiences
• Attention to detail and a commitment to delivering high-quality work under tight deadlines

Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• A generous employee referral program