Biostatistician II
About Karius
Karius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI, we are driven to improve the diagnostic landscape for infectious diseases. Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions.
Position Summary The Biostatistician II supports the design, analyses and interpretation of clinical, observational, translational, and research studies with minimal guidance. This position owns defined statistical deliverables, develops statistical analysis plans, produces documentation for publication and regulatory submissions, and partners with cross-functional stakeholders to ensure analyses are scientifically rigorous, reproducible, and appropriately interpreted.
Why Should You Join Us? Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our tests are the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.
Reports to: Director, Clinical Statistics & Data Management
Location: Remote
Primary Responsibilities
- 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 appropriate 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 using appropriate statistical techniques.
- Support the design and analysis of prospective and retrospective clinical studies.
- Support exploratory analysis of Karius ’ large archive of commercial and research data as needed.
- Develop and validate statistical models to evaluate diagnostic performance, clinical outcomes, and other study endpoints.
- Analyze diagnostic performance measures, including sensitivity, specificity, diagnostic value, agreement measures, and other relevant metrics.
- Perform analyses involving longitudinal data, survival outcomes, missing data, confounding, subgroup analyses, and other complex data structures, as appropriate.
- Collaborate with Data Science, Bioinformatics, Clinical Development, Medical Affairs, and Research and Development teams to ensure statistical rigor and appropriate interpretation of results.
- Review datasets and analysis outputs for accuracy, completeness, consistency, and statistical validity.
- Independently manage assigned statistical analyses and deliverables.
- Interpret analytical findings and communicate results clearly to technical and non-technical audiences.
- Contribute statistical content to study reports, abstracts, manuscripts, posters, presentations, regulatory materials, and other scientific communications.
- Support responses to statistical questions arising during scientific, clinical, regulatory, or publication review.
- Develop robust, reusable s