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
