Staff Biostatistician

Job not on LinkedIn

🔥 5 minutes ago

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Karius

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2014

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Karius is a biotechnology company specializing in infectious disease diagnostics. The company uses genomics and artificial intelligence to detect microbial cell-free DNA from pathogens in the bloodstream, enabling the identification of over 1000 pathogens causing infections. Karius aims to transform infectious disease diagnosis with the help of clinical metagenomics, providing clear and timely diagnostic results. Their innovative Karius Test is a novel liquid biopsy designed to provide clinicians with comprehensive diagnostic insights into infections, even in immunocompromised patients.

📋 Description

• 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

• 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

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