Director

• Lead programming strategy across multiple clinical studies and development programs
• Oversee and manage internal programmers and external vendors/CRO partners
• Establish and maintain programming standards, processes, and best practices
• Support planning, timelines, and resourcing for all programming activities
• Provide oversight and hands-on support for the development and validation of SDTM, ADaM datasets, TLFs (Tables, Listings, Figures), integrated datasets for ISS/ISE
• Ensure all deliverables meet regulatory, statistical, and quality requirements
• Guide the implementation of programming workflows using SAS and/or R
• Drive automation, reproducibility, and process efficiency within the programming team
• Partner closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams
• Serve as a key programming representative in study team meetings
• Support regulatory submissions, including eCTD-ready deliverables, reviewer guides, and traceability documents

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