Karius is a venture-backed life science startup that is transforming the way pathogens and other microbes are observed throughout the body. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to the microbial landscape to accelerate biomarker discovery and clinical trials, discover novel microbes, to ultimately reduce patient suffering worldwide.

Position Summary

The Senior Clinical Data Scientist plays a critical role in driving the extraction, analysis and interpretation of clinical trial data to support evidence-based decision making and drive the development of innovative healthcare solutions. This position requires a strong background in data analysis, statistical modeling, and clinical research methodologies. The ideal candidate will have a passion for leveraging data to improve patient outcomes and contribute to the advancement of medical knowledge.

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 Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is 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: Vice President, Clinical Affairs

Location: Redwood City, CA or Remote

Primary Responsibilities

• Collaborates on clinical study design and protocol development, authors and executes statistical analysis plans to support study endpoints, and conducts sample size calculations

• Develops statistical analysis programs to merge complex clinical data structures from multiple databases, create analysis data set and generate tables, listings, and figures for reports and peer-reviewed manuscripts

• Uses appropriate statistical, visual, and narrative displays of clinical data in a manner that is easily and appropriately interpreted by the target audience

• Interacts with members of the Data Management and Clinical Operations teams to align statistical endpoints of the clinical study to data collection, monitoring, and analysis activities

• Recognizes and resolves clinical protocol issues that may impact database design, data validation and/or analysis/reporting, minimizes the data footprint to focus on the trial endpoints

• Participates in the development of database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations

• Interprets and evaluates data and results of complex clinical studies and develops appropriate recommendations

• Collects, organizes, and interprets statistical information from clinical databases, coded data, and other specified data sets

What’s Fun About the Job?

Karius is operating at the edge of what is now known to be possible in infectious disease 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 5%.

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.

Position Requirements

• 5+ years experience at a life sciences (e.g. diagnostic, biotech, or pharmaceutical) company analyzing clinical datasets, proficient in SQL, Python, R, or SAS.

• Graduate degree in statistics, biostatistics, epidemiology, informatics, or a related field. Additional coursework in programming, analytics, or related disciplines is strongly desired. PhD preferred.

• Solid proficiency in statistical methodology, particular for statistical measures related to diagnostic test accuracy and power and sample size calculations.

• Knowledge of diagnostic clinical trial statistics is required.

• Experience with data visualization, translating clinical data and information into a visual context to support publication and results reporting.

• Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, survival analysis, and associated sample size calculations.

• Experience with the extraction of data and reporting within Clinical Data Management systems (e.g. Medidata RAVE, Medrio, Oracle Clinical).

• Familiar with ICD-10 and CPT codes, AHRQ quality indicators, and other similar healthcare-related tools and data, especially to support clinical impact, cost, and HCRU studies.

• Outstanding verbal, written, and presentation skills with a strong ability to influence and communicate effectively throughout all levels of the organization and externally.

Personal Qualifications

• Excellent analytical skills to interpret complex clinical data, identify trends, and draw accurate conclusions.

• Attention to detail to ensure data quality and accuracy.

• Critical thinking to be able to identify and solve problems, develop innovative solutions and make informed decisions.

• Team player with the ability to collaborate effectively cross-functionally and work as part of a team.

• Strong communication skills with the ability to communicate complex data analysis results to both technical and non-technical stakeholders

• Adaptability to new technologies and data sources, regulatory guidelines, and changing business needs.

At Karius, we value a diverse and inclusive workplace and provide equal employment opportunity for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at recruiting@kariusdx.com and we will accommodate qualified individuals with disabilities.

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