Karius
Karius
Karius — жұқпалы ауруларды диагностикалауға бағытталған биотехнологиялық компания. Оның клиникалық метагеномика платформасы патогендер қан айналымына бөлетін микробтық жасушасыз ДНҚ-ны анықтау үшін геномдық талдауды жасанды интеллектпен біріктіреді. Karius Test сұйық биопсиясы клиницистерге 1 000-нан астам патогенді анықтауға және, соның ішінде иммунитеті әлсіреген пациенттердегі инфекцияларды бағалау кезінде, диагностикалық тұрғыдан кеңірек түсінік алуға көмектесуге арналған. Компания озық зертханалық және есептеу әдістері арқылы жұқпалы ауруларды диагностикалауды неғұрлым жан-жақты әрі уақтылы етуге бағытталған.

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.

Сипаттама

  • 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.

Талаптар

  • 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.

Артықшылықтар

  • 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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