Senior Programmer, EDC Systems

Role: Senior EDC Programmer responsible for governance, review, and validation of clinical data management system deliverables to ensure compliance with CSL standards and regulatory requirements. Core responsibilities include designing, developing, and maintaining clinical study databases; collaborating with cross-functional teams to define data quality standards; overseeing data validation frameworks; supporting data integration from external sources; and contributing to future-state data platform initiatives with scalable and AI-enabled solutions. Requirements: BSc in Computer Science, Mathematics, or related; 5+ years in clinical database design within pharma or CRO settings; proficiency with EDC systems like Medidata Rave; strong knowledge of CDISC standards (CDASH, SDTM); experience with data validation, quality oversight, and vendor deliverables; Medidata Rave Study Builder Certification preferred. Additional skills include excellent communication, organizational abilities, and the capacity to operate in matrix environments. Preferred: familiarity with C#, SAS, Python, R, and data migration activities. High-Value: clinical data management, SDTM/CDASH standards, Medidata Rave, data validation, scalable data platforms, automation, AI-driven initiatives. Work Setup: hybrid, at least 3 days onsite weekly in Waltham, MA.