Remote opportunity at
NateraStaff Biostatistician (Clinical Validation)
Natera, a global leader in cell-free DNA testing focusing on organ health, women’s health, and oncology, is seeking a Staff Biostatistician for its Clinical Validation team.…
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About This Role
Natera, a global leader in cell-free DNA testing focusing on organ health, women’s health, and oncology, is seeking a Staff Biostatistician for its Clinical Validation team. This remote, full-time position involves supporting molecular diagnostic tests by driving the strategy, design, and analysis of clinical validation studies. The role focuses heavily on germline projects and kidney disease initiatives. The person in this position will independently lead study designs for in vitro…
Job Description
Natera, a global leader in cell-free DNA testing focusing on organ health, women’s health, and oncology, is seeking a Staff Biostatistician for its Clinical Validation team. This remote, full-time position involves supporting molecular diagnostic tests by driving the strategy, design, and analysis of clinical validation studies. The role focuses heavily on germline projects and kidney disease initiatives.
The person in this position will independently lead study designs for in vitro diagnostic approvals such as PMAs, 510(k)s, and companion diagnostics. Responsibilities include ensuring regulatory compliance with FDA standards, authoring statistical analysis protocols and reports, and acting as the statistical lead on interdisciplinary project teams. The ideal candidate will also mentor junior team members, evaluate new statistical methods, and participate in clinical research trials and publications.
Natera provides a collaborative work environment featuring professionals from various fields. The total compensation package for remote workers in the United States ranges from $164,000 to $205,000 USD, determined by factors such as experience, skills, and specific location.
Responsibilities
- Independently lead the design, analysis, and interpretation of clinical validation studies for in vitro diagnostic approvals
- Ensure statistical methodologies satisfy FDA standards and drive interactions with regulatory authorities
- Author comprehensive statistical analysis reports, protocols, and presentations for internal and external stakeholders
- Act as the statistical lead on project teams by partnering with data management, product, and clinical science departments
- Develop and execute high-impact research studies, clinical trials, and publications
- Mentor and provide technical supervision to less experienced team members
Requirements
- Master's degree or Ph.D. in statistics, biostatistics, or a related discipline
- Minimum of 8 years of relevant industry experience in biotechnology, molecular diagnostics, or a related field
- Demonstrated background in regulated environments, including prior IVD or CDx submission experience
- Experience working with next-generation sequencing, genetic, and germline data
- At least 4 years of practical experience utilizing R statistical analysis software
Qualifications
- Prior experience with germline assay development
- Prior experience working on kidney disease projects
Core Skills
Benefits
- Comprehensive medical, dental, vision, life, and disability insurance plans
- Free genetic testing for employees and their immediate families
- Fertility care benefits
- Pregnancy and baby bonding leave
- 401(k) retirement benefits
- Commuter benefits
- Employee referral program
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, the posting lists the employment location as remote within the USA.
What is the salary range for the Staff Biostatistician role?
For remote workers in the United States, the pay range is $164,000 to $205,000 USD, depending on factors such as candidate experience, skill set, and location.
What education is required for this job?
Candidates must hold a Master's degree or a Ph.D. in Biostatistics, Statistics, or a related field.
What kind of experience is needed for this position?
Applicants need at least 8 years of relevant industry experience in molecular diagnostics, biotechnology, or similar fields, including regulated environment experience and a minimum of 4 years of practical experience with R.
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