JobMesh

Principal Programmer ( Data Oversight & Standards)

CSL · King Of Prussia, Pennsylvania, US

Principal Programmer - Clinical Data Oversight & Standards provides leadership and oversight for clinical data build, programming, and vendor deliverables ac...

Job description

Principal Programmer - Clinical Data Oversight & Standards provides leadership and oversight for clinical data build, programming, and vendor deliverables across in-house, hybrid, and outsourced studies, ensuring alignment with CSL standards, regulatory requirements, and industry best practices. The role drives governance, review, and validation processes; leads the implementation of CDASH and SDTM standards; and oversees scalable validation frameworks and data quality controls. Additionally, it ensures effective integration of internal and external data into platforms such as the CSL Clinical Data Warehouse, while advancing automation, AI-driven solutions, and strong cross-functional collaboration with Biostatistics, Data Management, Standards, and external partners Main Responsibilities and Accountabilities: - Leads and develops a team of Clinical Data Validation Programmers, providing direction on clinical data standards, validation, and oversight activities across in-house, hybrid, and vendor-supported studies. - Establishes and drives clinical data governance frameworks, including review and validation processes for eCRF builds, SDTM datasets, specifications, and vendor delive...