POSITION SUMMARY: 

This is an exciting opportunity to advance Natera’s regulated product portfolio of cutting-edge molecular diagnostic tests. As a Staff Biostatistician, you will leverage your strong applied statistics and IVD expertise to oversee the design, analysis, and interpretation of analytical and clinical validation studies for complex biomarkers used in the detection, monitoring, and management of cancer. 

PRIMARY RESPONSIBILITIES: 

Lead Biostatistics efforts designing and executing development, analytical, and clinical studies to support in vitro diagnostic approvals (e.g., IVDR, 510(k), PMA, etc.) 

Lead interactions with regulatory authorities

Lead statistical calculations and analyses for studies of varying complexity

Promote statistical and regulatory best practices  

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

Stay current with advancements in Biostatistics and analytical/clinical validation methodology, implementing innovative approaches to support product development and regulatory submissions

Mentor and provide technical supervision to junior team members

Perform other duties as assigned 

QUALIFICATIONS: 

Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.

At least 8 years of experience in Biostatistics, preferably within molecular diagnostics, biotechnology, or related fields.

Demonstrated experience in regulated environments.

Experience evaluating next-generation sequencing (NGS), genetic, and/or oncology-related data.

Minimum of 4 years practical experience with statistical analysis software such as R (preferred), SAS, or JMP.

KNOWLEDGE, SKILLS, AND ABILITIES: 

Expert working knowledge of statistical methodology in diagnostic medicine, including an understanding of CLSI and 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 complex biomarkers (e.g., TMB, MSI, Methylation) preferred.

Experience in design of both non-clinical (analytical) and clinical studies desired.

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.

 

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$155,600—$194,500 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, 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