Lead Biostatistician (Analytical Validation)

Natera

6h • $134,400 - $168,000 • Remote

About The Position

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 detection, monitoring, and management of cancer.

Requirements

• 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 (preferred), 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
• Track record of producing high quality written documentation for multiple audiences

Nice To Haves

• Prior experience with next-generation sequencing (NGS), genetics, and/or oncology diagnostics. Familiarity with DNA methylation a plus

Responsibilities

• 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
• Perform other duties as assigned

Benefits

• Employee benefits include 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.
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more.
• We also offer a generous employee referral program!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level