Lead Biostatistician (IVD Clinical)

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 clinical trials for regulatory submissions to support our oncology portfolio.  PRIMARY RESPONSIBILITIES: Design and review statistical methodology in protocols and statistical analysis plans Lead execution of statistical analyses according to plans and protocols, as well as exploratory or ad-hoc analyses  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 Perform other duties as assigned QUALIFICATIONS: 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 At least 3 years practical experience designing and executing statistical analyses in a regulated environment and clinical trials for regulatory submissions Minimum of 4 years practical experience with statistical analysis software such as R (preferred), SAS, or JMP Previous diagnostic experience preferred KNOWLEDGE, SKILLS, AND ABILITIES: Expert knowledge of probability theory and statistics including the ability to evaluate and produce novel methods and applications Familiarity with typical approaches, best practices, and regulatory standards in clinical trial design 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 Track record of producing high quality written documentation for multiple audiences Prior experience with next-generation sequencing (NGS), genetics, and/or oncology testing a plus Previous experience interacting with regulatory bodies such as the FDA preferred Compensation & Total Rewards  This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of  hire. Final compensation will vary based on experience, qualifications, and internal equity considerations. This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including: 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 Additional wellness and work-life benefits Compensation Range $144,000—$180,000 USDOUR OPPORTUNITY Natera™ ...