and maintaining deep expertise in the various data collection tools applied in the clinical trials such as DTAs, ClinicalData Tools such as LSAF and Pinnacle 21, and in CDISCstandards such as STDM, CDASH, Controlled Terminology, and define.xml. Principal Relationships Internal: Align, collaborate, advise, and share best practices with other functions and teams in Therapeutic Areas, Global Development, Regulatory More ❯
Oxford, England, United Kingdom Hybrid / WFH Options
JR United Kingdom
CSRs. Author, review, and approve study TFL shells and dataset specifications. Develop, validate, and document SAS programs, ensuring good programming practices. Identify data issues and outliers. Review and approve CDISC Validation reports. Resolve or escalate data and standards issues. Stay updated on emerging standards and their impact. Maintain proficiency in SAS and stay aware of developments. Keep study master files More ❯
data exploration and visualization. Application of statistical methodology and concepts in clinical trial analysis, including experience with R-Shiny apps for data exploration. Advanced knowledge of industry standards including CDISCdata structures and a solid understanding of the development and use of standard programs. In-depth understanding of the phases of clinical trials and the drug development process. #J More ❯
and RWE studies is desirable. Proven ability to apply R and R-Shiny for analysis and reporting, with skills in data visualization and wrangling. Knowledge of industry standards like CDISCdata structures. Deep understanding of clinical trial phases and drug development process. IQVIA is a leading provider of clinical research services and healthcare insights. Learn more at https:// More ❯
clinical trial results into value dossier and regulatory submission packages Lead development of statistical programs using SAS for regulatory and non-regulatory submissions (pre-defined and post-hoc) Implement CDISCstandards as required for project deliverables Conduct QC programming for descriptive and complex studies in RWD Contribute to writing study reports and use of visualization tools for reporting and dataMore ❯
Reading, Berkshire, United Kingdom Hybrid / WFH Options
ICON
and overall quality in a client-facing capacity (project leadership track only) Advanced/expert-level of project leadership/technical track, respectively, working knowledge of data structures (e.g., CDISC SDTM, ADaM), software development lifecycle and their implementation Strong working knowledge of the types of risks associated with a study and the impact on key parameters, such as study timelines More ❯