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

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.