Lead/Staff Biostatistician (Analytical Validation)

Remote from: USA
Annual salary: Undisclosed
Salary information is not provided for this position. Check our Salary Directory to estimate the average compensation for similar roles.
Department: Data Science & Analytics
Employment type: Full Time,
Job posted: 22 Jul 2026
Apply before: 22 Aug 2026
Experience level: Senior
Views / Applies: 36 / 3

About company

About Natera

Transforming patient care through genetic testing and precision medicine.

Biotechnology
2004

Actively Hiring

AI Summary

Natera is seeking a Lead/Staff Biostatistician to independently lead biostatistics efforts for its oncology portfolio of molecular diagnostic tests. The role involves strategic study design, cross-functional leadership, regulatory compliance, and innovation in statistical methods. Candidates require a PhD or Master's in Biostatistics/Statistics with 5-8 years of industry experience in analytical validation. This remote position offers a competitive salary range of $130,900–$205,000 USD.

Role DNA

Job Complexity

Easy Hard

Pace & Pressure

Relaxed Fast-paced

Autonomy Level

Guided Full Ownership

Communication Load

Independent Highly Collaborative

AI Insight The role demands expert-level statistical knowledge, leadership in complex validation studies, and regulatory expertise, making it highly challenging but not the highest level due to existing frameworks.

Salary Analysis

AI Insight The offered salary range of $130,900–$205,000 is competitive for a senior biostatistician in the diagnostics industry, reflecting the required expertise and leadership responsibilities.

Core Skills Required

Biostatistics Analytical Validation Oncology CLSI Guidelines Regulatory Compliance Cross-functional Leadership Study Design Statistical Methodology Communication Problem-solving

Cover Letter Sample

Dear Hiring Manager,

I am writing to express my strong interest in the Lead/Staff Biostatistician position at Natera. With a PhD in Biostatistics and over 7 years of experience in analytical validation for diagnostic tests, I have a proven track record of leading study designs and driving cross-functional teams to regulatory success. My expertise in CLSI guidelines and statistical methodology aligns perfectly with the requirements of this role.

In my previous role at a leading biotech firm, I independently managed multiple validation studies, ensuring compliance with FDA and CLIA standards. I am adept at communicating complex statistical concepts to non-technical stakeholders and thrive in collaborative environments. I am excited about the opportunity to contribute to Natera's innovative oncology portfolio and advance patient care.

Thank you for considering my application. I look forward to discussing how my skills can support Natera's mission.

Sincerely, [Your Name]

Sample Interview Questions

Describe your experience with designing and analyzing analytical validation studies for diagnostic tests. Can you walk us through a specific example?

In my previous role, I led the analytical validation of a liquid biopsy test for cancer. I designed studies to assess limit of detection, precision, and accuracy, collaborating with lab scientists to define acceptance criteria. We used CLSI guidelines for protocols and submitted results to the FDA, achieving approval.

How do you ensure statistical methodologies meet regulatory standards such as CAP/CLIA and FDA requirements?

I stay updated on regulatory guidelines and apply them from study design to reporting. For FDA submissions, I ensure studies follow CLSI EP documents and include sample size justification, randomisation, and blinding. I also work closely with regulatory affairs to review protocols.

Explain a time when you had to communicate complex statistical results to a non-technical executive audience. How did you approach it?

I presented validation results to the VP of R&D, using visual aids like graphs and simplified metrics. I focused on key findings, such as sensitivity and specificity, and used analogies to explain statistical significance. I ensured the message highlighted actionable insights.

How do you handle competing priorities when leading multiple high-priority projects simultaneously?

I prioritize by impact and deadlines, using project management tools to track progress. I communicate with stakeholders to align expectations and allocate resources. For example, during a product launch, I balanced validation studies by delegating tasks and setting milestone check-ins.

What innovative statistical methods have you applied in your recent work, and how did they improve outcomes?

I implemented a Bayesian hierarchical model for a multi-site validation study, which improved precision by borrowing strength across sites. This reduced sample size requirements while maintaining power, accelerating the study timeline by 30%.

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 5 years (Lead) or 8 years (Staff) 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, AND 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

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

$130,900—$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!

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/

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.

For more information:
– BBB announcement on job scams
– FBI Cyber Crime resource page

Apply now >