Natera
Staff Biostatistician (Clinical Validation)
San Carlos, CA · Staff+
Sponsorship not specified$180k-$226kDetected 6 days ago
StatisticsComplianceClinical TrialsClinical ResearchFDA RegulatoryNGSMedical DevicesResearchExperimental DesignLeadershipCommunicationCollaborationPublic SpeakingBiostatistics
Stay score
odds of building a lasting career here
61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card filing pattern in this occupation
Context, not a finding about this posting: of this employer's 24 green-card filings in this occupation, 96% were for a worker who already held the job.
Green-card follow-through: 88%
Of 17 labor certifications old enough to have been used, 2 expired without the employer filing the next step. Median time from filing to decision: 497 days.96% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.
Files H-1B transfers
15 transfer filings in the last year, covering 15 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- This is an exciting opportunity to advance Natera's regulated product portfolio of cutting-edge molecular diagnostic tests.
- When you join Natera, you'll work hard and grow quickly.
- We also offer a generous employee referral program!
Responsibilities
- Stay current with advancements in Biostatistics and clinical validation methodology, implementing innovative approaches to support diagnostic product development and regulatory submissions
- Strategic Study Design and Analysis: Independently lead the design, analysis, and interpretation of clinical validation studies to support in vitro diagnostic approvals (e.g., CDx, 510(k), PMA, etc.)
- Regulatory Compliance: Ensure statistical methodologies and analyses meet the standards set by regulatory agencies such as FDA. Drive statistical interactions with regulatory authorities.
- Cross-Functional Leadership: Serve as the statistical lead on high-priority project teams.
- Partner with Clinical Science, Data Management, and Product teams to integrate statistical expertise into project planning and execution.
- Clinical Research and Beyond: Drive design and execution of high-impact research clinical trials, studies, and publications that push the development of our world-class product portfolio
- As a Staff Biostatistician, you will leverage your strong applied statistics, IVD, and Clinical Research expertise to drive the strategy, design, analysis, and interpretation of clinical validation studies for kidney disease and other high-priority germline projects.
- Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
Requirements
- At least 8 years of relevant industry experience, preferably within molecular diagnostics, biotechnology, or related fields.
- Demonstrated experience in regulated environments, including previous CDx or IVD submission experience
- Experience with next-generation sequencing (NGS), genetic, and/or germline-related data.
- Minimum of 4 years practical experience with R statistical analysis software
- Ph.D. or Master's degree in Biostatistics, Statistics, or a related field
Skills
- Expert working knowledge of statistical methodology in diagnostic medicine, including an understanding of 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 germline assay development preferred
- Prior experience with kidney disease 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.
- Annual performance incentive bonus
- Long-term equity awards
- Comprehensive health benefits (medical, dental, vision)
- 401(k) with company match
Compensation
- $180,400 - $225,500 USD
Benefits
- 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.
- Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
Company info
- 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.
- We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives.
Equal opportunity
- Equal Opportunity Employer.
This listing is sourced directly from Natera's careers page and normalized into a canonical job model.