POSITION SUMMARY: 

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics and IVD expertise to oversee the design, analysis, and interpretation of analytical and clinical validation studies for complex biomarkers used in the detection, monitoring, and management of cancer. 

PRIMARY RESPONSIBILITIES: 

• Lead Biostatistics efforts designing and executing development, analytical, and clinical studies to support in vitro diagnostic approvals (e.g., IVDR, 510(k), PMA, etc.) 

• Lead interactions with regulatory authorities

• Lead statistical calculations and analyses for studies of varying complexity

• Promote statistical and regulatory best practices  

• 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

• Stay current with advancements in Biostatistics and analytical/clinical validation methodology, implementing innovative approaches to support product development and regulatory submissions

• Mentor and provide technical supervision to junior team members

• Perform other duties as assigned 

QUALIFICATIONS: 

• Ph.D. or Master’s degree in Biostatistics, Statistics, or a related field.

• At least 8 years of experience in Biostatistics, preferably within molecular diagnostics, biotechnology, or related fields.

• Demonstrated experience in regulated environments.

• Experience evaluating next-generation sequencing (NGS), genetic, and/or oncology-related data.

• Minimum of 4 years practical experience with statistical analysis software such as R (preferred), SAS, or JMP.

KNOWLEDGE, SKILLS, AND ABILITIES: 

• Expert working knowledge of statistical methodology in diagnostic medicine, including an understanding of CLSI and FDA guidelines. 

• Previous experience interacting with regulatory bodies such as the FDA.

• Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds.

• Strong track record of producing high quality written documentation for multiple audiences. 

• Prior experience with complex biomarkers (e.g., TMB, MSI, Methylation) preferred.

• Experience in design of both non-clinical (analytical) and clinical studies desired.

• Strong communication skills, with the ability to explain complex statistical concepts to non-statistical audiences.

• Attention to detail and a commitment to delivering high-quality work under tight deadlines.