Senior Clinical Programmer I

About the role

We are seeking a Senior Clinical Programmer I to join our team. This role involves leading clinical programming activities, collaborating with cross-functional teams, and driving process improvements.

Responsibilities

• Lead clinical programming activities across assigned studies, ensuring project timelines, budgets, deliverables, and resource needs are effectively managed while proactively identifying and escalating risks or change orders.
• Design, build, validate, and maintain clinical databases, electronic edit checks, data listings, and data visualization tools to support high-quality data collection, review, and regulatory compliance.
• Collaborate cross-functionally with Data Management, Project Management, Biostatistics, and study teams to develop study documentation, clarify technical specifications, and deliver programming solutions that meet project objectives.
• Champion industry standards and quality, applying CDISC conventions (CDASH, TAUGs, and SDTM models), validation principles, and programming best practices to ensure consistent, compliant, and inspection-ready deliverables.
• Drive innovation and continuous improvement by leading process enhancements, developing global programming standards and libraries, implementing data analytics and visualization tools, and supporting departmental initiatives.

Requirements

• Minimum 5 years of experience in drug development and/or clinical research.
• Good understanding and hands-on experiences of CDISC standards (i.e. CDASH, TAUGs and SDTM models).
• Expert with electronic data capture (EDC) software systems and other tools for managing clinical studies.
• Expert in technical data management practices (developing programs, validation plans, testing, and documentation).