Experienced I Clin Programmer

In this role you will be an experienced clinical programmer leading complex data management activities for trials. You will develop data models, SDTM tabulations, and study-specific reports to support safety, risk, and regulatory submissions. You will ensure data quality, implement current standards, and contribute to process improvements within a cross-functional team. This position offers the chance to influence data-driven decisions and impact health outcomes at a global scale.

• Accountable for one or more clinical programming trial activities of moderate to high complexity, scope and/or criticality
• Review project requirements, identify gaps, propose solutions, and improve efficiency of programming tasks
• Ensure latest standards and technologies are deployed
• Create/review specifications for data review models and SDTM submissions (aCRF, define.xml, cSDRG)
• Program/oversee quality checks and study-specific reports for safety, risk, and data consumers
• Programmatically aggregate diverse clinical data sources into fit-for-purpose data models and reporting solutions
• Support and/or lead process, system, and tool improvement initiatives within regulatory compliance

• Experience leading or contributing to clinical programming activities of moderate to high complexity
• Creation/review of data mapping specifications and SDTM packages for health authority submissions
• Design of data review models and mapping algorithms for nonstandard conversions
• Strong data quality and verification practices in clinical data environments
• Ability to translate study needs into actionable reporting specifications
• Knowledge of regulatory requirements and CDISC standards
• Data modeling and data integration skills
• Proven programming capability to support reporting and data management

• Detail-oriented
• Analytical reasoning
• Team collaboration
• SAS Programming
• CDISC SDTM
• Data Modeling