Senior Biostatistician (Analytical Validation)

Natera

23h • Remote

About The Position

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.

Requirements

• 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

Nice To Haves

• Experience designing and executing statistical analyses in a regulated environment a plus
• 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

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

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!

What This Job Offers

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