Lead/Staff Biostatistician (Analytical Validation)

Natera; San Carlos (CA); On-site; USD 180,400 - 225,500; Full time

Benefits offered by this job

Annual performance incentive bonus

401(k) with company match

Generous paid time off

Comprehensive medical, dental, vision plans

Employee referral program

Job summary

Natera in California is seeking a Staff Biostatistician to independently lead Biostatistics efforts for oncology molecular diagnostic tests. This role involves strategic study design, cross-functional leadership, and ensuring compliance with regulatory standards.

The ideal candidate will have a Ph.D. or Master's in Biostatistics, along with 8 years of experience in analytical validation. This position offers competitive benefits, including annual bonuses, comprehensive health coverage, and a conducive work environment for professionals in genetic testing.

Qualifications

• Minimum 8 years of relevant industry experience, with a focus on analytical validation.
• Deep understanding of CLSI guidelines.

Responsibilities

• Lead design, analysis, and interpretation of analytical validation studies.
• Serve as the statistical lead on high-priority project teams.
• Prepare comprehensive protocols and reports for stakeholders.
• Ensure compliance with regulatory agencies.
• Provide leadership on statistical methods for studies.

Skills

Expert-level knowledge of statistical methodology

Exceptional problem-solving skills

Exemplary written and verbal communication skills

Ability to work on cross-functional teams

Education

Ph.D. or Master's degree in Biostatistics

Job description

This is an exciting opportunity to independently lead Biostatistics efforts advancing Natera’s oncology portfolio of cutting‑edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics expertise to drive the strategy and execution of complex validation experiments for multiple high‑priority projects. The ideal candidate will possess exceptional communication skills and a deep understanding of Biostatistics in analytical validation.

Primary Responsibilities

• Strategic Study Design and Analysis: Independently lead the design, analysis, and interpretation of analytical validation studies for oncology products.
• Cross‑Functional Leadership: Serve as the statistical lead on multiple high‑priority project teams. Partner with bench scientists, bioinformatics, and product development teams to integrate statistical expertise into project planning and execution. Identify risks, communicate concerns, and champion solutions to interdisciplinary teams.
• Documentation and Reporting: Prepare comprehensive protocols and reports for cross‑functional collaborators and stakeholders.
• Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as CAP/CLIA, NYS, and the FDA.
• Innovation and Improvement: Provide leadership on the application of both common and cutting‑edge statistical methods for studies of varying complexity.

Qualifications

• Minimum 8 years of relevant industry experience, with a focus on analytical validation in diagnostics, biotechnology, or related industries.
• Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.

Knowledge, Skills, & Abilities

• Expert‑level knowledge of statistical methodology in diagnostic medicine, including a deep understanding of CLSI guidelines.
• Exemplary written and verbal communication skills, with a specific talent for presenting to non‑technical executive leadership.
• Demonstrated ability and enthusiasm for working on cross‑functional teams with members of diverse technical backgrounds.
• Exceptional problem‑solving skills and attention to detail.

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.

• Annual performance incentive bonus
• Long‑term equity awards
• 401(k) with company match
• Generous paid time off and company holidays
• Additional wellness and work‑life benefits

Compensation Range

$180,400 – $225,500 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, 401(k) 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.

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

Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

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