Staff Biostatistician

kariusdx; United States; À distance; USD 110 000 - 150 000; Plein temps

Résumé du poste

Karius is seeking a Biostatistician II to design, analyze, and interpret clinical and translational studies with minimal guidance. You will own defined statistical deliverables, develop analysis plans, and partner with cross-functional stakeholders to ensure rigorous, reproducible analyses.

The role reports to the Director, Clinical Statistics & Data Management. Location is remote in the United States, with travel as needed for team events.

Qualifications

• Master's degree in Biostatistics, Statistics, Epidemiology, Applied Statistics, or related field.
• Experience designing and interpreting clinical studies is preferred.
• Strong skills in statistical programming and reproducible analyses.

Responsabilités

• Independently perform statistical analyses for clinical studies and research initiatives.
• Partner with clinical scientists to define objectives, endpoints, hypotheses, and methods.
• Develop analysis plans including sample size, power, and populations.
• Validate analyses and communicate results to technical and non-technical audiences.
• Contribute to study reports, regulatory materials, and scientific communications.

Connaissances

Statistical analyses

Study design

Power calculations

Longitudinal data

Survival analysis

Missing data

Subgroup analyses

Statistical modeling

Data interpretation

Documentation

Formation

Master's degree in Biostatistics

Outils

R

SAS

Python

Description du poste

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 statistical programs, workflows, and documentation that support reproducible analyses.
• Maintain appropriate documentation of statistical methodologies, assumptions, analyses, and results.
• Contribute to continuous improvement of statistical processes, standards, and analytical approaches.

What's Fun About the Job?

Karius is operating at the edge of what is now known to be possible in diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.

Travel: Travel required up to 15% for team events.

Physical Requirements

Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, lab or clinical environment.

Position Requirements

Master's degree in Biostatistics, Statistics, Epidemiology, Applied Statistics, or a relat