Support programming activities for multiple projects on clinical study reports and publications
Accountable for clinical statistical programming deliverables and for ensuring excellence in programming activities in terms of quality and timelines for clinical trials under the responsibility of Statistics & Data Management
Collaborate with Statistics, Data Management, Clinical, and vendor teams to clarify requirements and resolve data or programming issues
Develop, validate, and maintain SAS programs in accordance with study requirements, internal standards, and SOPs
Contribute to the creation, validation, and documentation of SDTM and ADaM datasets
Responsible for producing programming outputs, validation, and related documentation to ensure accuracy, consistency, and traceability
Ensure deliverables meet expectations in terms of timelines and quality, regulatory and key user group requirements (e.g., CDISC), operational efficiency, and alignment with the study's clinical and statistical objectives
Provide input into SAP, analysis specifications, and data presentations for clinical trials
Support ongoing workflow modernization, migration activities, and standardization initiatives
Participate in process improvement activities related to programming efficiency, quality, and standardization
Requirements
Bachelor’s degree or higher in statistics, mathematics, computer science, life sciences, data science, or related field
Relevant experience in clinical trial programming, clinical data analysis, statistical programming, or regulated data environments
Strong SAS programming skills, including data step, procedures, macros, and debugging
Ability to write clear, validated, reusable, and well-documented code
Understanding of programming quality control, validation, and traceability expectations
Working knowledge of CDISC standards, especially SDTM and ADaM
Ability to support dataset creation, validation, listings, tables, figures, and ad hoc analyses
Understanding of clinical trial data flow from data collection to analysis/reporting
Strong attention to detail and quality
Ability to work independently on assigned tasks with appropriate guidance
Good communication skills and ability to collaborate with Statistics, Data Management, Clinical, and external vendors
Ability to manage priorities and timelines in a changing project environment