Lead Biostatistician (IVD Analytical)

Natera; San Carlos (CA); On-site; USD 144,000 - 180,000; Full time

Benefits offered by this job

Long-term equity awards

Comprehensive health benefits

401(k) with company match

Paid time off and holidays

Wellness and work-life benefits

Fertility care benefits

Job summary

Natera is seeking a Lead Biostatistician to oversee design, analysis, and interpretation of statistical work for regulated molecular diagnostics used in cancer management. You will lead analytical validation studies supporting CLIA LDT and regulatory submissions, and mentor junior statisticians.

The role emphasizes collaboration with cross-functional teams, clear communication of complex methods, and CLSI-guided practices in a regulated environment.

Qualifications

• Master’s in biostatistics or equivalent with 5+ years of experience, or PhD with 3+ years.
• Previous diagnostic experience.
• Minimum of 4 years practical experience with R, SAS or JMP.
• Experience designing analyses in a regulated environment.

Responsibilities

• Lead biostatistics analyses for analytical validation in CLIA LDT and regulatory submissions.
• Perform sample size, power, agreement, precision, and LoD calculations for validation studies.
• Produce high-quality presentations and documentation of plans, methods, results, and interpretation.
• Explain statistical concepts to cross-functional teams and stakeholders.
• Identify risks and champion solutions within interdisciplinary projects.
• Mentor and supervise junior statisticians.

Skills

Analytical skills

Communication

Cross-functional collaboration

Education

Master’s degree in biostatistics or related field

PhD in biostatistics or related field

Tools

R

SAS

JMP

Job description

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

Compensation & Total Rewards

This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.

This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including:

• Long-term equity awards
• Comprehensive health benefits (medical, dental, vision)
• 401(k) with company match
• Generous paid time off and company holidays
• Additional wellness and work-life benefits

Compensation Range

$144,000—$180,000 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!

For more information, visit www.natera.com.

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.

If you are based in California, we encourage you to read this important information for California residents.

Link: https://www.natera.com/notice-of-data-collection-california-residents/