Senior Clinical Data Research Engineer

Cytovale is a company focused on medical affairs, and they are seeking a Senior Clinical Data Research Engineer. The role involves data analysis and curation from large clinical datasets to support clinical trial design and reporting.

Responsibilities:

• Interpret clinical case reports and develop an understanding of the 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

Requirements:

• Advanced degree in biomedical engineering, bioengineering, or related field
• 5+ years of experience working with large clinical data sets, preferably in an FDA regulated environment
• Proficiency in coding for data analysis, e.g. Python, R; including data science packages and tools (pandas, numpy, matplotlib) required
• 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, regressions, etc.) is required, 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 minimum direct oversight
• A passion for understanding complex issues with a data-driven approach, experimenting and iterating on different ways to solve a problem