Senior Programmer, Clinical Data Evaluation

The Senior Programmer for Data Validation supports cross-functional teams by overseeing and ensuring the quality of clinical data build and programming activities across in-house, hybrid, and vendor-supported studies. The role focuses on governance, review, and validation of deliverables to ensure alignment with CSL standards, regulatory requirements, and industry best practices.

Requirements

• Collaborate with clinical study teams, Standards, and cross-functional stakeholders to define, implement, and continuously enhance data quality methods, acceptance criteria, and validation rules for eCRF and external data sources across all study models
• Oversee the implementation and maintenance of data quality control frameworks, including validation check libraries and acceptance criteria for vendor and internally generated data, ensuring alignment with CSL standards and regulatory expectations
• Govern and maintain a standardized library of reports and listings to support study teams, ensuring consistency, reusability, and efficiency across in-house, hybrid, and vendor-supported studies
• Oversee the setup, automation, and monitoring of recurring data quality and operational reports across different models (in-house vs outsourced etc.) ensuring accuracy, completeness, and timely availability of outputs
• Partner with Data Management, Statistics, and vendors to review and validate clinical data deliverables, ensuring submission readiness in accordance with regulatory standards (e.g., SDTM, ADaM, define.xml)
• Lead the development and oversight of data visualization and reporting solutions that provide insights into data quality, study progress, and key metrics to support informed decision-making
• Ensure appropriate data structures, storage, and integration approaches that enable pooled analyses, traceability, and efficient retrieval of both current and legacy clinical data
• Serve as a subject matter expert in CDASH, SDTM mapping, and EDC systems, providing guidance on data standards, eCRF design, and validation approaches to internal teams and external partners
• Support the integration and governance of external data sources (e.g., IxRS, eDiaries, labs, ECG), ensuring data consistency, quality, and alignment with study requirements, while facilitating collaboration between internal teams and vendors
• Contribute to innovation and future-state initiatives by supporting the development of scalable data platforms, automation strategies, and AI-enabled capabilities to enhance data processing, validation, and analytics

Benefits

• Comprehensive medical, dental, and vision insurance
• 401(k) retirement savings plan
• Paid time off and holidays
• Professional development and growth opportunities
• Equal opportunity employer