Natera
Lead Biostatistician (Clinical)
Job Summary
This role involves leading the biostatistics efforts supporting Natera’s molecular diagnostic products, focusing on study design, data analysis, and regulatory submissions for oncology tests. The candidate will provide technical leadership, conduct statistical analyses, and develop analysis plans and reports, ensuring regulatory compliance. A strong background in biostatistics and experience with clinical trials, ideally in regulated environments, are required. The position emphasizes cross-functional collaboration and adherence to regulatory standards while promoting statistical best practices.
Required Skills
Benefits
Job Description
This is an exciting opportunity to lead the Biostatistics efforts supporting Natera’s product portfolio of cutting-edge molecular diagnostic tests. As Lead Biostatistician, you will leverage your strong applied statistics background to oversee the design, analysis, clinical trials, and regulatory submissions to support our oncology portfolio.
PRIMARY RESPONSIBILITIES:
- Provide technical leadership in the design and execution of all phases of clinical trials.
- Perform relevant statistical analyses (e.g., sample size, power, survival, sensitivity, specificity)
- Design and review statistical methodology in statistical analysis plans and protocols
- Execute statistical analyses according to plans and protocols, as well as exploratory or ad-hoc analyses
- Produce high quality written documentation including study protocols, statistical analysis plans and reports, and regulatory submissions
- Effectively convey statistical concepts and results to cross-functional internal and external collaborators and stakeholders
- Promote statistical best practices
- Act as an internal statistical consultant to other functional groups or their members by providing expert advice on statistical methodology
- Perform other duties as assigned
QUALIFICATIONS:
- Master’s degree in biostatistics, statistics, or equivalent with 6+ years of relevant experience, or PhD in biostatistics, statistics, or equivalent with 3+ years of relevant experience
- At least 2 years practical experience designing and executing statistical analyses in a regulated environment and clinical trials for regulatory submissions such as FDA
- Previous diagnostic experience preferred
- Minimum of 4 years practical experience with statistical analysis software such as R (preferred), SAS, or Python.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Expert knowledge of probability theory and statistics including the ability to produce novel methods based on first principles understanding
- Demonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgrounds
- Familiarity with typical approaches, best practices, and regulatory standards in clinical trial design
- Ability to produce high quality written documentation for varying audiences
- Ability to work independently while managing multiple objectives and timelines
- Desire to work in a fast-paced environment with potential for high impact in a small team
- Familiarity with Regulatory submissions, preferred
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
Natera
Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care.
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