Senior Biostatistician (Analytical Validation)

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Senior Biostatistician, you will leverage your strong applied statistics background to design and implement statistical analysis and reporting of development and analytical validation studies for complex biomarkers used in the detection, monitoring, and management of cancer. PRIMARY RESPONSIBILITIES: With minimal guidance, drive the design and execution of analyses for analytical validation studies in support of CLIA LDT and in vitro diagnostic (e.g., IVDR, 510(k), PMA, etc.). Perform relevant statistical analyses (e.g., sample size, power, agreement, precision, LoD calculations) for studies of varying complexity With minimal guidance, produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation Effectively convey statistical concepts and results to cross-functional collaborators and stakeholders When challenges arise, identify risks, communicate concerns, and present potential solutions to interdisciplinary project teams Perform other duties as assigned QUALIFICATIONS Master’s degree in biostatistics, statistics, or equivalent with 3+ years of relevant experience; or PhD in Biostatistics, Statistics, or equivalent with 1+ years of relevant experience Minimum of 2 years practical experience with statistical analysis software such as R (preferred), SAS, or JMP Experience designing and executing statistical analyses in a regulated environment a plus KNOWLEDGE, SKILLS, AND ABILITIES: Expert applied 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 Ability to produce high quality written documentation for varying audiences Prior experience with next-generation sequencing (NGS), genetics, and/or oncology diagnostics or DNA methylation a plus The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. Remote USA $120,300 $150,400 USD OUR OPPORTUNITY 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. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com . Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and o ... (truncated, view full listing at source)