Assist in the development and implementation of solutions to DM service issues and concerns regarding SAAMA programming and testing activities, including proactive prevention strategies. Develop and maintain programs for creation of datasets as per specifications. Develop programs to import external data and transform to SAS Dataset or Excel files for data review and reconciliation. Maintain study databases for assigned projects. Perform programming for any regular or ad-hoc reports/listings as needed by the Study/Sponsor teams using available tools/SAS/Spotfire.

Summary of Responsibilities:

• Proactively learn to design and execute processes related to programming, setup for data analysis using SAAMA tool.
• Perform the following duties with the guidance from Senior staff: Database design, EDC/SAS edit programming, listings, ad-hoc/scheduled reports using SAS/Cognos/Business Objects – XI, R and other tools for data cleaning and reporting.
• Complete assigned work utilizing EDC tools or SAS or other proprietary software according to Fortrea SOPs, Work Instructions, and project-specific guidelines in accordance with Good Clinical Practices (GCP).
• Maintain knowledge and awareness of latest developments in CDISC standards and Statistical programming.
• Create CRF annotations and mapping specifications as per Clients/CDISC standards.
• Develop and maintain SAS programs for creation of SAS datasets as per the specifications.
• Develop programs to import external data and transform to SAS Dataset or Excel files for data review and reconciliation.
• Perform all work with knowledge of regulations pertaining to computerized systems to projects to ensure compliance and interact with project team members in related discipline.
• Continuously learn and improve communication, technical, and problem-solving skills.
• Provide regular status updates on the tasks assigned to Line Manager.
• All other duties as needed or assigned.