Clinical Data Analyst, Spotfire

The Spotfire Clinical Data Analyst will specialize in the installation, maintenance, and development of clinical data visualizations utilizing Spotfire. This role emphasizes creating and enhancing Spotfire-based patient profiles, real-time data review dashboards, clinical metrics dashboards, and other customized visualization reports such as live TLFs. Additionally, the Analyst will collaborate closely with Clinical Data Management, Biostatistics, Clinical Science, and Clinical Operations to optimize data visualization strategies.

Responsibilities:

• Lead the installation, configuration, and ongoing maintenance of Spotfire for clinical data analysis and visualization.
• Design, develop, and maintain Spotfire dashboards for patient profiles, real-time clinical data review, surveillance, metrics tracking, and other customized visualizations.
• Develop sophisticated, interactive visualizations to support internal data review processes, surveillance, reconciliation, and reporting needs.
• Collaborate with Clinical Data Managers, Biostatistics, Clinical Operations, and Clinical Science teams to identify requirements and translate them into effective Spotfire visualizations.
• Manage and continually improve the Spotfire analytics environment, ensuring data integrity, accuracy, and performance.
• Establish and maintain a Global Spotfire Library, aligning visualization standards across multiple studies and programs.
• Train and mentor Clinical Data Managers and other stakeholders in effectively utilizing Spotfire dashboards and reports.
• Coordinate timelines and deliverables with Clinical Data Management and other cross-functional teams to ensure visualizations meet expectations.
• Contribute to the evaluation and implementation of new technologies and methodologies to enhance Spotfire capabilities.
• Document visualization specifications, maintain clear documentation for Spotfire-related processes, and contribute to departmental SOPs.
• Uphold industry standards including protocol compliance, ICH GCP, FDA regulations, and CDISC standards (SDTM, ADaM).

Qualifications:

• Bachelor’s degree in Biostatistics, Computer Science, Life Science, or a related field.
• Minimum of 5 years of hands-on experience in Spotfire visualization development and administration in a clinical trial setting, preferably in oncology and hematology.
• Expert-level proficiency in Spotfire including installation, configuration, dashboard development, data integration, scripting (IronPython, TERR, etc.) and performance optimization.
• Strong experience developing patient profiles, real-time data review dashboards, clinical metrics dashboards, and complex reports.
• Experience with SAS/R, SQL programming, and data manipulation.
• Familiarity with clinical trial data standards (CDISC SDTM, ADaM), experience with TLF generation preferred.
• Experience integrating Spotfire with clinical databases and EDC systems (e.g., Medidata RAVE, Oracle Inform, Veeva).
• Strong organizational skills, critical thinking, and the ability to manage multiple projects simultaneously.
• Excellent verbal and written communication skills.
• Familiarity with regulatory guidelines including GCP, ICH, and FDA requirements.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).