Staff Biostatistician (Clinical Validation)

Natera; Oregon; Hybrid; USD 164,000 - 205,000; Full time

Job summary

Natera is seeking a Staff Biostatistician to lead the design, analysis, and interpretation of clinical validation studies for regulatory approvals, including CDx and other IVD submissions.

You will drive statistical methodologies that meet FDA standards, collaborate with Clinical Science, Data Management, and Product teams, and mentor junior staff while advancing germline and kidney disease projects. Remote USA options may apply.

Qualifications

• Ph.D. or Master's in Biostatistics, Statistics, or related field.
• At least 8 years of relevant industry experience, preferably within molecular diagnostics, biotechnology, or related fields.
• Demonstrated experience in regulated environments, including previous CDx or IVD submission experience
• Experience with next-generation sequencing (NGS), genetic, and/or germline-related data.
• Minimum of 4 years practical experience with R statistical analysis software

Responsibilities

• Lead the design, analysis, and interpretation of clinical validation studies for regulatory approvals (CDx, 510(k), PMA).
• Ensure statistical methodologies meet FDA standards and interact with regulatory authorities.
• Prepare SAPs, reports, and presentations for cross-functional and external collaborators and stakeholders.
• Serve as the statistical lead on high-priority project teams and collaborate with Clinical Science, Data Management, and Product teams.
• Drive design and execution of high-impact clinical validation studies and publications.
• Stay current with advancements in Biostatistics and clinical validation methodology, implementing innovative approaches.
• Mentor and provide technical supervision to junior team members

Skills

Statistical analysis

Regulatory experience

Cross-functional collaboration

Mentoring

Communication skills

Education

Ph.D. or Master's in Biostatistics or related field

Tools

R

NGS data analysis

Job description

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, IVD, and Clinical Research expertise to drive the strategy, design, analysis, and interpretation of clinical validation studies for kidney disease and other high-priority germline projects.

Primary Responsibilities

• Strategic Study Design and Analysis: Independently lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic approvals (e.g., CDx, 510(k), PMA, etc.)
• Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as FDA. Drive statistical interactions with regulatory authorities.
• Documentation and Reporting: Prepare comprehensive statistical analysis protocols (SAPs), reports, and presentations for cross-functional and external collaborators and stakeholders.
• Cross-Functional Leadership: Serve as the statistical lead on high-priority project teams. Partner with Clinical Science, Data Management, and Product teams to integrate statistical expertise into project planning and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams
• Clinical Research and Beyond: Drive design and execution of high-impact research clinical trials, studies, and publications that push the development of our world-class product portfolio
• Stay current with advancements in Biostatistics and clinical validation methodology, implementing innovative approaches to support diagnostic product development and regulatory submissions
• Mentor and provide technical supervision to junior team members

Qualifications

• Education: Ph.D. or Master's degree in Biostatistics, Statistics, or a related field
• Experience:
• At least 8 years of relevant industry experience, preferably within molecular diagnostics, biotechnology, or related fields.
• Demonstrated experience in regulated environments, including previous CDx or IVD submission experience
• Experience with next-generation sequencing (NGS), genetic, and/or germline-related data.
• Minimum of 4 years practical experience with R statistical analysis software

Knowledge, Skills, and Abilities

• Expert working knowledge of statistical methodology in diagnostic medicine, including an understanding of 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 germline assay development preferred
• Prior experience with kidney disease desired
• Experience in design and analyses of clinical validation studies
• 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.

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$164,000—$205,000 USD

Our Opportunity

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

What We Offer

Competitive 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!

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.