Lead Biostatistician – IVD Analytical

Natera

. Lead Biostatistics efforts designing and executing analyses for analytical validation studies supporting CLIA LDT and in vitro diagnostic approvals, including IVDR, 510(k), and PMA .

Posted 11/9/2026full-timeRemote • United StatesSenior💰 $130,900 - $163,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in biostatistics and statistical analysis within regulated environments, particularly for diagnostic validation studies. Proficient in conveying complex statistical concepts to diverse audiences and mentoring junior team members.

Highest-signal resume keywords

Master's Degree In BiostatisticsStatistical Analysis Software (R)Statistical Methodology In Diagnostic MedicineExperience With Next-Generation Sequencing (NGS)Strong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisSample Size CalculationPower AnalysisPrecision CalculationLoD CalculationDocumentation AuthoringStatistical MethodologyRegulatory ExperienceDiagnostic ExperienceCLSI Guidelines

Soft Skills

MentoringCross-Functional CollaborationProblem-SolvingCommunication

Tools & Technologies

SASJMP

Industry Keywords

CLIA LDTIVDR510(k)PMADNA MethylationFDA NegotiationOncology DiagnosticsGenetics

About the role

Key responsibilities & impact

Lead Biostatistics efforts designing and executing analyses for analytical validation studies supporting CLIA LDT and in vitro diagnostic approvals, including IVDR, 510(k), and PMA
Perform statistical analyses including sample size, power, agreement, precision, and LoD calculations for validation studies
Produce presentations and author documentation of analysis plans, methods, results, and interpretation
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

Requirements

What you’ll need

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 (required) and 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
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
Strong track record of producing high quality written documentation for multiple audiences
Prior experience with next-generation sequencing (NGS), genetics, and/or oncology diagnostics
Familiarity with DNA methylation a plus
Experience negotiating with the FDA a plus

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
401k benefits
Commuter benefits
Employee referral program