5 of 5 CDISC Jobs in the Thames Valley

well as general knowledge of industry practices and standards.· Proficiency in R programming language and other statistical software, including EAST.· Experience with CDISC, including SDTM, ADaM, CDASH.· Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities.· Experience designing and conducting adaptive trials.#LI-LR1This role ...

within IQVIA is ideal for someone with a technical mindset, strong communication skills, and a good understanding of SDTM.Experience in Study Design, CRF annotation, CDISC standards, and vendor management will be key for success in this position. The role can be performed remotely from a number of countries in Europe ...

Commensurate experience will be considered.Minimum of 2 years of Clinical Data Management experience using electronic data capture systems. Familiarity with clinical research processes and CDISC/CDASH/SDTM standardsEffective oral and written presentation and communication skills.Strong attention to detail and a commitment to high quality work, customer service ...

moderate to high complexity/criticality. Including data model specifications, data stream integrations and transformation of source to internal data models and/or CDISC submission ready SDTM tabulation packages (aCRF, define.xml, cSDRG, etc). Creates and executes edit check programs, listings and report solutions to aid in monitoring …/or review specifications for mapping internal data review model for fit for purpose reporting and/or as well as submission ready CDISC SDTM. Design mapping algorithms for nonstandard conversions.• Responsible for creation or review of internal data model for fit for purpose reporting consumption and/or submission ...

requests, 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 coordinate environment … clinical 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 readiness ...