Spotfire Clinical Data Analyst

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:

Bachelors 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).