7 of 7 CDISC Jobs

strategic initiatives and partnerships across a matrixed organization.Oversee data ingestion, transformation, and validation processes for clinical trial data, ensuring compliance with GCP/GxP, CDISC, and SOPs.Collaborate with CROs and internal teams to optimize data flow, versioning, and retention policies.Build and optimize data pipelines for both structured and unstructured clinical … experience with oncology clinical trials, including regulatory-compliant management of clinical biomarker data and application of data standards (e.g., Clinical Data Interchange Standards Consortium [CDISC], Study Data Tabulation Model [SDTM], Analysis Data Model [ADaM]).Deep familiarity with FAIR (Findable, Accessible, Interoperable, Reusable) data principles, data harmonization, and enterprise data governance ...

/MACRO, SQL and SAS/BASE procedures, SAS/GRAPH and Statistical procedures. Demonstrable knowledge of regulatory requirements (FDA, ICH), such as CDISC, SDTM/ADaM IG etc. Defines and drives the global technical strategy for programming automation, standardization and advanced analytics capabilities within Global Biometry. Identifies and implements ...

Holdings Inc is seeking a Senior Biostatistician in the United Kingdom to lead statistical analyses across clinical trial phases. The role emphasizes SAS programming, CDISC SDTM/ADaM knowledge, and collaboration with sponsors and cross-functional teams. Ideal candidates will have a Biostatistics/Statistics/Mathematics degree (MS/ ...

specifications, while driving process improvements and training teammates. The role requires strong SAS Viya, R, and Python skills, plus experience with CDISC standards and regulatory deliverables. Collaborative, client-focused, and regulatory-compliant work is expected. #J-18808-Ljbffr ...

procedures.Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC StandardsWhen serving … subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML)When serving as a subject matter expert for CDISC and other industry and regulatory ...

Department on upcoming changes to those standards. May contribute to presentations at industry conferences and roundtables. When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well ...

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 ...