Lead Biostatistician (IVD Analytical)
Natera
Summary
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.
Job description
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
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 (required) and 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
- 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
Benefits
- Medical, Dental & Vision
- Life & Disability Insurance
- Free Testing
- Fertility Care Benefits
- Pregnancy & Baby Bonding Leave
- 401(k) Benefits
- Commuter Benefits
- Employee Referral Program
Company overview
Natera is a global leader in cell-free DNA (cfDNA) testing, specializing in molecular diagnostics for oncology, women's health, and organ health. Founded in 2004 and headquartered in Austin, Texas, the company has developed a cutting-edge cfDNA technology platform that combines novel molecular biology techniques with bioinformatics software and artificial intelligence. Natera's proprietary technology enables detection down to a single molecule in a tube of blood, making it possible to provide highly accurate genetic testing services. The company's flagship products include Signatera, a personalized circulating tumor DNA test for cancer monitoring; Panorama, a non-invasive prenatal test for chromosomal abnormalities; and Prospera, a transplant rejection assessment test. With over 4,400 employees and operations in CLIA-certified, CAP-accredited laboratories in Austin and San Carlos, California, Natera has processed more than 12 million tests and validated its technology through over 300 peer-reviewed publications. The company went public in 2015 and continues to innovate in precision medicine, aiming to make personalized genetic testing part of standard healthcare to enable earlier interventions and improved patient outcomes.