Staff Biostatistician – Clinical Validation

Natera

. Independently lead the design, analysis, and interpretation of clinical validation studies supporting in vitro diagnostic approvals, including CDx, 510(k), and PMA submissions .

Posted 10/14/2026full-timeRemote • United StatesLead💰 $164,000 - $205,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in biostatistics and statistical methodologies for clinical validation studies, with a strong focus on regulatory submissions and cross-functional collaboration. Proven ability to mentor junior team members and communicate complex statistical concepts effectively to diverse audiences.

Highest-signal resume keywords

Ph.D. Or Master's Degree In Biostatistics8 Years Of Relevant Industry ExperienceExpert Working Knowledge Of Statistical Methodology In Diagnostic Medicine4 Years Practical Experience With R Statistical Analysis SoftwareExperience With Next-Generation Sequencing (NGS)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisClinical Validation StudiesRegulatory SubmissionsBiostatistical MethodologiesGermline Assay DevelopmentClinical Trial DesignStatistical Protocol PreparationData AnalysisFDA Guidelines ComplianceRisk Identification And Mitigation

Soft Skills

Strong Communication SkillsAttention To DetailTeam CollaborationMentoringProblem-Solving

Tools & Technologies

R Statistical Analysis SoftwareStatistical Analysis ProtocolsPresentation Software

Industry Keywords

In Vitro Diagnostics (IVD)Companion Diagnostics (CDx)Molecular DiagnosticsBiotechnologyNext-Generation Sequencing (NGS)Regulated EnvironmentsKidney Disease

About the role

Key responsibilities & impact

Independently lead the design, analysis, and interpretation of clinical validation studies supporting in vitro diagnostic approvals, including CDx, 510(k), and PMA submissions
Ensure statistical methodologies and analyses meet FDA and other regulatory agency standards
Drive statistical interactions with regulatory authorities
Prepare statistical analysis protocols, reports, and presentations for cross-functional and external collaborators and stakeholders
Serve as statistical lead on high-priority project teams
Partner with Clinical Science, Data Management, and Product teams on project planning and execution
Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams
Drive the design and execution of clinical trials, studies, and publications
Implement innovative biostatistical and clinical validation methodologies for diagnostic product development and regulatory submissions
Mentor and provide technical supervision to junior team members

Requirements

What you’ll need

Ph.D. or Master's degree in Biostatistics, Statistics, or a related field
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
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
Experience in design and analyses of clinical validation studies
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

Benefits

Comp & perks

Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
Free testing for employees and their immediate families
Fertility care benefits
Pregnancy and baby bonding leave
401(k) benefits
Commuter benefits
Employee referral program