Lead Biostatistician (IVD Analytical) New US Remote

Natera, Inc.; United States; Remote; USD 131,000 - 164,000; Full time

Benefits offered by this job

Medical, dental, vision

Life and disability plans

401k benefits

Fertility care benefits

Job summary

Natera, Inc. is seeking a Lead Biostatistician to oversee design, analysis, and interpretation of R&D and analytical validation studies for complex biomarkers used in cancer management.

You will apply applied statistics and IVD expertise in a regulated environment, contributing to CLIA LDT and external approvals across several pathways. The role emphasizes mentoring junior staff, presenting results, and collaborating with cross-functional teams.

Qualifications

• Master’s degree in biostatistics or equivalent with 5+ years of relevant experience, or PhD with 3+ years of relevant experience
• Minimum of 4 years practical experience with R (required) and SAS or JMP
• Experience designing and executing statistical analyses in a regulated environment

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

Skills

Biostatistics expertise

Statistical analysis

Regulatory environment knowledge

Communication skills

Mentoring

Education

Master’s degree in biostatistics

PhD in biostatistics

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
• Minimum of 4 years practical experience with statistical analysis software such asR (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

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 - $163,600 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.

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.

Natera values transparency and fair hiring practices. Disclosure of a family relationship does not automatically disqualify you from employment. This information helps us comply with our internal policies on conflicts of interest and reporting structures.