Clinical SAS Programmer

• Creating and executing SAS edit check programs
• Validating edit check programs using standard validation practices and processes
• Creating, validating and executing SAS programs and macros
• Utilizing SAS programming skills to provide ad-hoc reports (external and internal) and participating in project meetings (internal and external)
• Assist in developing programming specifications and in creating program specific validation plans
• Identifying and implementing solutions for complex reporting needs
• Creating and/or reviewing data editing and export specifications
• Working directly with clinical data manager and where needed with clinical project manager and other team members to ensure specifications are clear and accurate.
• Has a clear understanding of the contextual requirements for reporting outputs; and provides feedback
• Programming data cleaning/consistency checking programs to support internal applications for all therapeutic areas
• Programming and testing data export programs in accordance with specific client needs
• Documenting all programming and validation efforts in accordance with Good Clinical Practices
• Monitoring data integrity throughout a given study and utilizing SDTM guidelines to create transfer datasets
• Participating in the development of data editing conventions, specification documents and Clinical Data Management (CDM) processes
• Contributing to, designing and maintaining a library of reusable code
• Leading and managing enhancements to current CDM systems and providing inputs in the implementation of new systems
• Working independently and efficiently with minimal input required from the Reviewing timelines; and projecting estimates and target dates in conjunction with direct supervisor and project team
• Adhering to target dates for project timelines and communicating any changes in target date to appropriate personnel including Project Manager
• Keeping department head informed of progress as well as potential impediments
• Adhering to established processes and standards
• Reading, understanding and adhering to organizational Standard Operating Procedures (SOP)
• Assisting in establishing and enforcing departmental standards
• Maintain and review clinical programming SOPs and participating in the modification of company SOPs
• Working with internal staff to resolve issues and exploring new opportunities to add value to organization and departmental processes
• Helping others to achieve results and performing other duties as assigned
• Attending and participating in applicable company-sponsored training