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Karius
Karius
51 – 200 Angajați
Sponsor pentru viza H1BAlimente și băuturiAsistență medicalăConsultanță
Karius este o companie de biotehnologie axată pe diagnosticarea bolilor infecțioase. Platforma sa clinică de metagenomică îmbină analiza genomică și inteligența artificială pentru a identifica ADN-ul microbian fără celule, eliberat în fluxul sanguin de agenții patogeni. Testul Karius este o biopsie lichidă concepută pentru a ajuta medicii să detecteze peste 1.000 de agenți patogeni și să obțină o perspectivă diagnostică mai amplă, inclusiv în evaluarea infecțiilor la pacienții imunocompromiși. Activitatea companiei se concentrează pe îmbunătățirea complexității și rapidității diagnosticării bolilor infecțioase prin metode avansate de laborator și de calcul.
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Locurile de muncă ale companiei

Staff Biostatistician – California Remote

Staff Biostatistician supporting Karius’s infectious-disease diagnostics platform through clinical, genomic, and real-world data analysis. The role develops statistical plans, models, and regulatory analyses to support diagnostic evaluation and patient care.

USStatele Unite ale AmericiiCACaliforniaRemoteNormă întreagăLiderLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Lead independent statistical analyses for clinical studies, research programs, product development, and evidence-generation initiatives.
  • Establish study objectives, endpoints, hypotheses, and statistical methods with clinical and scientific stakeholders.
  • Prepare statistical analysis plans covering sample size and power calculations, analysis populations, methods, and sensitivity analyses.
  • Evaluate clinical, observational, laboratory, and real-world datasets.
  • Contribute to the design and analysis of prospective and retrospective clinical studies.
  • Investigate Karius’s commercial and research data archive.
  • Create and validate statistical models for diagnostic performance, clinical outcomes, and other study endpoints.
  • Assess sensitivity, specificity, diagnostic value, agreement measures, and related diagnostic performance metrics.
  • Conduct analyses involving longitudinal data, survival outcomes, missing data, confounding, and subgroups.
  • Partner with Data Science, Bioinformatics, Clinical Development, Medical Affairs, and Research and Development teams.
  • Examine datasets and analytical outputs for accuracy, completeness, consistency, and statistical validity.
  • Own assigned statistical analyses and associated deliverables.
  • Interpret results and present findings to technical and non-technical audiences.
  • Provide statistical input for reports, abstracts, manuscripts, posters, presentations, regulatory materials, and scientific communications.
  • Help address statistical questions raised during scientific, clinical, regulatory, and publication reviews.
  • Build reusable statistical programs, workflows, and documentation that support reproducible analyses.
  • Document methodologies, assumptions, analyses, and results.
  • Help improve statistical processes, standards, and analytical methods.

Cerințe

  • Master’s degree in Biostatistics, Statistics, Epidemiology, Applied Statistics, or a related quantitative discipline required; PhD preferred.
  • Three to five years of relevant biostatistics experience in biotechnology, diagnostics, pharmaceuticals, healthcare, academia, or another life sciences setting.
  • Background designing and analyzing clinical, observational, or translational research studies.
  • Experience preparing statistical analysis plans that define endpoints, sample size and power calculations, analysis populations, and statistical methods.
  • Strong knowledge of regression, categorical data, longitudinal, survival, missing-data, and confounding analyses.
  • Experience analyzing highly multiplexed clinical assays.
  • Proficiency in R and/or SAS for statistical programming 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 oversee statistical analyses and advise cross-functional partners.
  • Familiarity with regulatory requirements, Good Clinical Practice, and statistical practices in regulated life sciences environments preferred.
  • Strong analytical, problem-solving, and critical-thinking abilities.
  • Excellent written and verbal communication skills.
  • Ability to manage competing priorities and collaborate effectively in a fast-paced, cross-functional environment.

Beneficii

  • Travel of up to 15% may be required for team events.
  • Equal employment opportunities are provided.
  • Accommodations are available for qualified individuals with disabilities.

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