WIRB-Copernicus Group

SUMMARY OF POSITION: 

The Clinical Data Analyst analyzes clinical trial data using Analgesic Solutions' Quantitative Statistical Surveillance System and Service (QDSS). QDSS is used to look for aberrant signals in data that may indicate a problem that could affect a trial's outcome. The Analyst works with subject matter experts to evaluate the relevance of signals and recommend analysis-driven interventions. The Analyst recommends and implements new tools and processes to improve the analysis pipeline and the visualization of data signals. The Analyst presents data to study sponsors and gathers feedback from them on the results of interventions.

EDUCATION REQUIREMENTS:

Bachelors Degree in Biology, Chemistry, Mathematics, Statistics or similar field

QUALIFICATIONS/EXPERIENCE:

• 5+ years in a clinical field or environment
• 3 years’ experience in Clinical Data Analysis
• Familiarity with clinical data sets, clinical trial protocols, and FDA, ICH, and GCP guidelines
• Experience working in a clinical setting is highly desired.
• Thorough understanding of cross-functional clinical processes including data management and biostatistics
• Knowledge of development environment, classification, analytical and other software
• Working knowledge of SQL, Python, R, etc., is preferred
• Experience with data mining and visualization tools such as Tableau, Spotfire, R, etc. is preferred
• Ability to work in teams and collaborate with others to clarify requirements

ESSENTIAL DUTIES/RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily.  The requirements listed below are representative of the knowledge, skills, and/or ability required.

• Identify, manage and analyze aberrant clinical trial data signals from Analgesic Solutions' Quantitative Data Surveillance System (QDSS)
• Recommend interventions to address any clinically relevant aberrancies, may include collaborating and consulting with subject matter experts.
• Create presentation of data findings and present to clients on a regular basis.
• Provide ongoing analysis on data trends and results to improve the efficiency of data management and the algorithms used for analysis
• Work with others in the Data Science and Technology group to implement applications, tools, and processes for data management and data analysis using Analgesic Solutions' systems.
• Identify opportunities to innovate and improve product and the company’s capabilities and help drive prioritization of product features
• Conduct testing and provide clinical guidance into the development piece.
• Provide clinical expertise and guidance to all stages of development, from product ideation through architecture, documentation, implementation, testing, and support
• Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

SUPERVISORY RESPONSIBILITIES:  n/a

TRAVEL REQUIREMENTS:  This role may require up 10% travel which may be domestic or international, including overnight and weekend stays as necessary, consistent with project needs and office location.