5 of 5 CDISC Jobs in the South East

Expertise in data cataloging, metadata management, data classification, data governance, or a closely related discipline. Knowledge of clinical and health data standards, such as CDISC SDTM or ADaM and controlled terminology; familiarity with OMOP, HL7 FHIR, HealthDCAT-AP, or DCAT-AP is an advantage. Understanding of EHDS data holder obligations ...

settings Strong SAS proficiency (Base/Macro/Stat/Graph); familiarity with R or other languages is a plus Working knowledge of current CDISC standards — CDASH, SDTM, ADaM, define.xml Track record of producing and validating submission‐ready TFLs and datasets, including ad‐hoc analytical requests Experience supporting regulatory submissions ...

settings Strong SAS proficiency (Base/Macro/Stat/Graph); familiarity with R or other languages is a plus Working knowledge of current CDISC standards CDASH, SDTM, ADaM, define.xml Track record of producing and validating submission-ready TFLs and datasets, including ad hoc analytical requests Experience supporting regulatory submissions ...

data management practices. Experience working with Clinical Data Management and Electronic Data Capture (EDC) systems. Knowledge of Good Clinical Data Management Practices (GCDMP) and CDISC Study Data Tabulation Model (SDTM) standards. Experience within Medical Devices/Pharma/Clinical industry. Strong project and resource management skills with ability to manage ...

making sure they are complete, accurate, and delivered on time. You will configure study structures, repositories, datasets, reporting components, and access in line with CDISC and governance requirements. You will manage role-based access, study configurations, and Git/Azure DevOps resources using approved requests and compliant processes. You will … trial results generation, reporting, and submission processes. You have experience supporting Statistical Computing Environments, including process flows, user access, and Biometrics requirements. You understand CDISC standards, including SDTM and ADaM, and have worked with Tables, Figures, and Listings. You have worked in regulated pharmaceutical environments and understand SDLC, validation, audit ...