Staff Biostatistician

Karius

. Independently perform statistical analyses for clinical studies, research initiatives, product development activities, and evidence-generation efforts .

Posted 10/5/2026full-timeRemote • California • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical analysis for clinical studies, including the development of statistical analysis plans and proficiency in statistical programming with R and/or SAS. Strong ability to communicate complex findings to diverse audiences and manage multiple priorities in a collaborative environment.

Highest-signal resume keywords

Statistical Analysis PlansR ProgrammingSAS ProgrammingBiostatistics ExperienceClinical Study Design

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisRegression AnalysisLongitudinal AnalysisSurvival AnalysisSample Size CalculationsPower CalculationsData Quality AssessmentStatistical ValidationSensitivity AnalysisDiagnostic Performance Metrics

Soft Skills

Analytical SkillsProblem-Solving SkillsCritical ThinkingCommunication SkillsCollaboration Skills

Certifications & Qualifications

Master’s Degree in BiostatisticsPhD in Related Field Preferred

Industry Keywords

Good Clinical Practice (GCP)BiotechnologyDiagnosticsPharmaceuticalsHealthcareLife SciencesClinical ResearchTranslational ResearchRegulatory SubmissionsScientific Communications

About the role

Key responsibilities & impact

Independently perform statistical analyses for clinical studies, research initiatives, product development activities, and evidence-generation efforts
Define study objectives, endpoints, hypotheses, and statistical methodologies with clinical and scientific stakeholders
Develop statistical analysis plans, including sample size and power calculations, analysis populations, statistical methods, and sensitivity analyses
Analyze clinical, observational, laboratory, and real-world datasets
Support prospective and retrospective clinical study design and analysis
Explore Karius’ commercial and research data archive
Develop and validate statistical models evaluating diagnostic performance, clinical outcomes, and other study endpoints
Analyze sensitivity, specificity, diagnostic value, agreement measures, and other diagnostic performance metrics
Perform analyses involving longitudinal data, survival outcomes, missing data, confounding, and subgroup analyses
Collaborate with Data Science, Bioinformatics, Clinical Development, Medical Affairs, and Research and Development teams
Review datasets and analysis outputs for accuracy, completeness, consistency, and statistical validity
Manage assigned statistical analyses and deliverables
Interpret findings and communicate results to technical and non-technical audiences
Contribute statistical content to reports, abstracts, manuscripts, posters, presentations, regulatory materials, and scientific communications
Support responses to statistical questions during scientific, clinical, regulatory, or publication review
Develop reusable statistical programs, workflows, and documentation for reproducible analyses
Maintain documentation of methodologies, assumptions, analyses, and results
Contribute to continuous improvement of statistical processes, standards, and analytical approaches

Requirements

What you’ll need

Master’s degree in Biostatistics, Statistics, Epidemiology, Applied Statistics, or a related quantitative field required; PhD preferred
3–5 years of relevant biostatistics experience in biotechnology, diagnostics, pharmaceuticals, healthcare, academia, or a related life sciences environment
Experience designing and analyzing clinical, observational, or translational research studies
Experience developing statistical analysis plans, including study endpoints, sample size and power calculations, analysis populations, and statistical methodologies
Strong knowledge of regression analysis, categorical data analysis, longitudinal analysis, survival analysis, missing data, and confounding
Experience analyzing highly multiplexed clinical assays
Proficiency in statistical programming using R and/or SAS required
Experience working with complex clinical, biological, genomic, or real-world datasets
Strong understanding of data quality, analytical reproducibility, statistical validation, and documentation practices
Experience contributing statistical analyses to clinical study reports, abstracts, manuscripts, presentations, or regulatory submissions
Ability to independently manage statistical analyses and provide statistical guidance to cross-functional partners
Familiarity with regulatory requirements, Good Clinical Practice (GCP), and statistical practices within regulated life sciences environments preferred
Strong analytical, problem-solving, and critical-thinking skills
Excellent written and verbal communication skills
Ability to manage multiple priorities and collaborate effectively in a fast-paced, cross-functional environment

Benefits

Comp & perks

Travel required up to 15% for team events
Equal employment opportunities
Accommodation for qualified individuals with disabilities