Lead Biostatistician (IVD Analytical)

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will leverage your strong applied statistics and IVD expertise to oversee the design, analysis, and interpretation of R&D and analytical validation studies for complex biomarkers used in the screening, monitoring, and management of cancer.

• →Lead Biostatistics efforts designing and executing analyses for analytical validation studies in support of CLIA LDT and in vitro diagnostic approvals (e.g., IVDR, 510(k), PMA, etc.).
• →Perform relevant statistical analyses (e.g., sample size, power, agreement, precision, LoD calculations) for validation studies of varying complexity
• →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
• →Mentor and provide technical supervision to junior team members

• Master’s degree in biostatistics, statistics, or equivalent with 5+ years of relevant experience, or PhD in biostatistics, statistics, or equivalent with 3+ years of relevant experience
• Previous diagnostic experience
• Minimum of 4 years practical experience with statistical analysis software such as 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 an understanding of CLSI guidelines 
• Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
• Strong communication skills, with the ability to explain complex statistical concepts to non-statistical audiences
• Strong track record of producing high quality written documentation for multiple audiences. Experience negotiating with the FDA a plus
• Prior experience with next-generation sequencing (NGS), genetics, and/or oncology diagnostics. Familiarity with DNA methylation a plus

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.