Lead Biostatistician (Analytical Validation) jobs in United States
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Natera · 22 hours ago

Lead Biostatistician (Analytical Validation)

Natera is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. As a Lead Biostatistician, you will oversee the design, analysis, and interpretation of R&D and analytical validation studies for complex biomarkers used in cancer detection and management.

BiotechnologyGeneticsHealth DiagnosticsMedicalWomen's
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H1B Sponsor Likelynote

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
Perform other duties as assigned

Qualification

BiostatisticsStatistical analysis softwareRegulated environment experienceStatistical methodologyNext-generation sequencingCommunication skillsMentoringCross-functional teamwork

Required

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
Previous diagnostic experience
Minimum of 4 years practical experience with statistical analysis software such as R (preferred), SAS, or JMP
Experience designing and executing statistical analyses in a regulated environment
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
Track record of producing high quality written documentation for multiple audiences

Preferred

Prior experience with next-generation sequencing (NGS), genetics, and/or oncology diagnostics
Familiarity with DNA methylation

Benefits

Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
Free testing in addition to fertility care benefits
Pregnancy and baby bonding leave
401k benefits
Commuter benefits
Generous employee referral program

Company

Natera specializes in cell-free DNA testing to provide a more targeted interventions to oncology, women's health, and organ health.

H1B Sponsorship

Natera has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (90)
2024 (72)
2023 (37)
2022 (71)
2021 (64)
2020 (40)

Funding

Current Stage
Public Company
Total Funding
$1.16B
Key Investors
Matthew Rabinowitz,Roelof BothaSofinnova InvestmentsHarmony Partners,OrbiMed
2023-09-07Post Ipo Equity· $250M
2022-11-15Post Ipo Equity· $400.05M
2022-03-16Post Ipo Equity· $5M

Leadership Team

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Steve Chapman
CEO
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Jonathan Sheena
Co-Founder, Board Member
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Company data provided by crunchbase