Key Facts

Remote From:

Anywhere

Full time

Senior (5-10 years)

English

Hard Skills

Other Skills

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Teamwork
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Analytical Thinking
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Presentations

Roles & Responsibilities

Bachelor’s degree in biomedical engineering, bioengineering, or a related field; Master’s or PhD preferred, particularly in a quantitative or life sciences discipline
5+ years of medical device related experience working with clinical data and complex diseases
Proficiency in coding for data analysis using Python (pandas, numpy, matplotlib, scikit-learn) and SQL relational databases
Familiarity with AI/ML tools and large language model (LLM) applications a plus

Requirements:

Interpret clinical case reports and develop understanding of clinical science of immune-mediated conditions (including sepsis) to inform study design and content of case report forms
Support the design, interpretation, reporting, and publication of clinical studies, including endpoint design, EDC builds, and study execution
Perform data analysis and develop data-driven models for disease/outcome trends, assay clinical utility, and value proposition
Collaborate with cross-functional teams to map current-state sepsis workflows and clinical processes in the emergency department and gather data

Cytovale

About Cytovale

Cytovale is a medical diagnostics company focused on providing a more rapid and insightful way to diagnose fast-moving and immune-mediated diseases. Our FDA cleared IntelliSep test is pioneering a new way of quickly and accurately analyzing white blood cells to stratify a patient’s risk of sepsis by performing a biomechanical evaluation of white blood cells collected from a standard blood draw in under 10 minutes. Cytovale’s first market application will be for sepsis, one of the fastest-moving, most lethal conditions in the world. Sepsis, a dysregulated immune response to infection, is often difficult to quickly and accurately diagnose. Sepsis is the no. 1 cause of death in hospitals, taking the lives of 270,000 people every year in the U.S. – more than opioid overdoses, prostate cancer, and breast cancer combined. Mortality from sepsis increases as much as eight percent with every hour of delayed treatment, and as much as 80 percent of sepsis deaths could be prevented with rapid diagnosis and treatment, making early detection essential. Cytovale aims to provide critical insight for early identification of patients at risk of having sepsis, in the time needed for it to be useful. Follow us on Twitter: twitter.com/cytovale

Founded: 2018

Company size: 51 - 200

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Job description

The Senior Clinical Data Research Engineer will be an individual contributor in the Medical Affairs department. The role will encompass data analysis and curation from multiple large clinical datasets to inform internal reports, external presentations, manuscripts, and publications, and to inform future clinical trial design.

This is a remote role.

Responsibilities:

Interpret clinical case reports and develop an understanding of clinical science of immune-mediated conditions, including sepsis, to inform study design and content of case report forms
Support the design, interpretation, reporting, and publication of clinical studies, including detailed participation in clinical endpoint design and process, supporting EDC builds, and study execution.
Perform data analysis and develop data-driven models for disease and outcome trends, value proposition, and assay clinical utility
Support quality improvement activities for customers by building systems and tools for post-implementation data analysis
Utilize data to track the performance and effectiveness of the IntelliSep solution in improving clinical outcomes, operational efficiency, and financial performance, and provide insights into customer-related metrics and the potential impact on patient outcomes and hospital reimbursement
Collaborate with cross-functional teams to gather data and gain insights into current-state workflows and performance related to sepsis management and clinical workflows within the emergency department
Appropriately apply visualization best practices and data storytelling techniques and deliver a clear and concise presentation of findings tailored to the audience
Develop documentation and methodologies for analyses and deliverables
Develop statistical models using clinical and biological data to inform clinical trial design
Write statistical analysis plans, including statistical methodology and programming procedure
Contribute analysis and graphs to educational and marketing materials, company reports, and scientific publications

Qualifications:

Bachelor’s degree required in biomedical engineering, bioengineering, or a related field; Master's or PhD preferred, particularly in a quantitative or life sciences discipline
5+ years of medical device related experience working with clinical data and complex diseases
Proficiency in coding for data analysis using Python, including data science packages and tools (pandas, numpy, matplotlib, scikit-learn) required. Experience with SQL and relational databases required. Familiarity with AI/ML tools and large language model (LLM) applications a plus
Strong analytical skills with the ability to interpret and present data effectively
Experience with designing research studies and interpreting data
Knowledge of statistics at the level needed for scientific publications (t-tests, survival analysis, regressions, etc.) is required; a deep background in statistics is a plus
A strong desire to work in a small, fast-paced environment of a late-stage startup
Candidate must be able to function as an individual contributor with minimal direct oversight
A passion for understanding complex issues with a data-driven approach, experimenting, and iterating on different ways to solve a problem.