Biostatistician II

Job not on LinkedIn

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $117.4k - $176.2k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 1%

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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 • Partner with clinical and scientific stakeholders to define study objectives, endpoints, hypotheses, and statistical methodologies • 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 the design and analysis of prospective and retrospective clinical studies • Perform exploratory analyses of commercial and research data • Develop and validate statistical models for diagnostic performance, clinical outcomes, and other study endpoints • Analyze diagnostic performance measures such as sensitivity, specificity, diagnostic value, and agreement measures • Perform analyses involving longitudinal data, survival outcomes, missing data, confounding, subgroup analyses, and other complex data structures • 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 • Independently manage assigned statistical analyses and deliverables • Interpret findings and communicate results to technical and non-technical audiences • Contribute statistical content to study 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 • Document statistical methodologies, assumptions, analyses, and results • Contribute to improving statistical processes, standards, and analytical approaches • Report to the Director, Clinical Statistics & Data Management

🎯 Requirements

• Master’s degree in Biostatistics, Statistics, Epidemiology, Applied Statistics, or a related quantitative field required • 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, and methods for addressing 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 • Strong analytical, problem-solving, and critical-thinking skills • Excellent written and verbal communication skills, including the ability to communicate complex statistical concepts to technical and non-technical audiences • Ability to manage multiple priorities and collaborate effectively in a fast-paced, cross-functional environment • PhD preferred • Proficiency with diagnostic test performance measures preferred • Experience with Python and SQL preferred • Familiarity with regulatory requirements, Good Clinical Practice (GCP), and statistical practices within regulated life sciences environments preferred • Demonstrated ability to work independently while recognizing when to seek input or escalate issues • Strong attention to detail and commitment to accuracy, quality, and scientific rigor • Strong organizational skills and ability to manage multiple priorities and deliverables • Collaborative and proactive approach to working with cross-functional partners • Ability to navigate ambiguity and adapt as study or business priorities evolve • Demonstrated accountability and ownership for assigned work • Commitment to continuous learning and improvement of statistical and analytical practices

🏖️ Benefits

• Full-time employment • Remote work option in the USA or hybrid work in Redwood City • Travel opportunities for team events, up to 15% • Opportunity to work with genomics, AI, and advanced diagnostic technologies • Equal employment opportunity and accommodation for qualified individuals with disabilities