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Key Responsibilities• Support the development, validation, and maintenance of statistical programming deliverables, including analysis datasets and reporting outputs (tables, listings, and figures) aligned with CDISC standards
• Perform data review and validation activities to ensure accuracy, consistency, and integrity of analysis results
• Create ADaM or ADaM-like programming specifications based on analysis definitions or SAP.
• Contribute to study-level deliverables, ensuring timelines and quality expectations are met
• Participate in submission-related activities, including preparation and review of supporting documentation and validation outputs
• Assist with continuous improvement efforts related to programming processes, standards, and efficiencies
Qualifications
• Bachelor’s or Master’s degree in a relevant field or equivalent experience
• Min. of 6 years of experience in statistical programming within a clinical or regulated environment