26 to 29 of 29 CDISC Jobs in the UK

type research‐ready and interoperable. Make clinical trial standards possible through import (from REDCap and other commercial EDC/CTMS solutions) and export (to CDISC SDTM) into capabilities investigators, sponsors, and study sites can effectively use. Implement validation and certification of D4L Collect including … Part 11, and EU Annex 11, including computer system validation and audit‐ready release management. Working fluency in clinical data standards, especially CDISC (SDTM, CDASH) at a conceptual level, and a working understanding of HIPAA + GDPR as they apply to clinical trials and real‐world data. Bachelor’s degree ...

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 ...

trials, collaborating with sponsors and cross‐functional teams to deliver high‐quality analyses in line with regulatory expectations. Strong SAS programming and CDISC SDTM/ADaM expertise are essential, as is the ability to manage projects and communicate clearly with clients and stakeholders. #J-18808-Ljbffr ...

consultancy across the stats function. You will lead design reviews, analysis plans, and reports for multiple sponsor projects. You will develop SAS programs, ensure CDISC/SDTM/ADaM compliance, maintain documentation, and contribute to manuscripts and bids. The role requires a Master's in math/stats ...