Staff Biostatistician (Clinical Validation) New US Remote

Natera, Inc.; United States; Remote; USD 164,000 - 205,000; Full time

Benefits offered by this job

US Remote

Competitive benefits

Equal Opportunity Employer

Job summary

Natera, Inc. in the United States is seeking an experienced biostatistician to independently lead the design, analysis, and interpretation of clinical validation studies that support in vitro diagnostic approvals (CDx, 510(k), PMA).

The role emphasizes regulatory-compliant methods and collaboration across clinical science, data management and product teams. You will prepare SAPs and reports, mentor junior statisticians, and drive high-impact research and regulatory submissions while staying

Qualifications

• Ph.D. or Master’s in Biostatistics required.
• 8+ years of biostatistics experience; CDx/IVD preferred.
• Experience with regulated environments and regulatory submissions (FDA).

Responsibilities

• Lead design, analysis, and interpretation of clinical validation studies for CDx/IVD approvals.
• Ensure regulatory-compliant statistical methodologies and analyses (FDA expectations).
• Prepare SAPs, reports, and presentations for cross-functional/external collaborators.
• Act as statistical lead on high-priority projects; partner with Clinical Science, Data Management and Product teams.
• Drive design and execution of clinical validation studies and publications.
• Mentor junior statisticians and provide technical supervision.

Skills

FDA guidelines

Cross-functional leadership

Clinical trial design

R statistical analysis

Regulatory submissions

Education

Ph.D. or Master's in Biostatistics

Tools

R

Job description

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.

US Remote

$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 are encouraged to apply, and 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.

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