Lead Biostatistician (IVD Analytical)

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 screening, monitoring, and management of cancer.

PRIMARY 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

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

Previous diagnostic experience

Minimum of 4 years practical experience with statistical analysis software such as R (required) and SAS or JMP

Experience designing and executing statistical analyses in a regulated environment

KNOWLEDGE, SKILLS, AND ABILITIES:

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

Strong track record of producing high quality written documentation for multiple audiences. Experience negotiating with the FDA a plus

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

The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.

Remote USA

$130,900—$163,600 USD