6 of 6 CDISC Jobs

relational databases, data modeling, and unstructured database technologies (e.g. NoSQL, Graph). Familiarity with containerisation (e.g. Docker, Kubernetes/EKS) and Agile working environments. Exposure to healthcare data standards (CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM) and relevant regulatory requirements. A Bachelor's degree in Computer Science, Statistics, Mathematics, Life Sciences, or related fields (Master's preferred). More ❯

skills in relational database design and modelling, with experience in NoSQL and Graph databases. Experience with containerisation (Docker, Kubernetes/EKS). Knowledge of healthcare data standards such as CDISC, HL7, FHIR, SNOMED CT, OMOP, and DICOM. Familiarity with big data technologies, MLOps, and model deployment. Bachelor's degree in a relevant field (Master's preferred) and 5-7 years More ❯

SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP). Ensure adherence to programming guidelines. Implement and follow the latest versions of CDISC, FDA Guidelines, GCP and other industry standards; Participate in and co-ordinate the Statistical Programming review of Case Report Forms (CRFs), annotated CRFs, database structures and study related documentation (e.g. More ❯

well as external vendors. Responsibilities: Represents programming function in Study Team meetings and interacts with functional colleagues from other departments Stay abreast of latest techniques in SAS Programming and CDISC Standards and continually improve internal processes to gain efficiency and regulatory compliance Develop complex SAS Macros that help in reducing redundant programming and increase efficiency in projects Motivate and mentor … to complete assigned deliverables Lead study/initiatives and utilize resources to meet corporate objectives Create specifications for data transformation in accordance to SDTM IG and SAP Creation of CDISC compliant deliverables - SDTM & ADaM datasets, annotated CRF (aCRF), define.xml, reviewer guides (SDRG/ADRG) Performing statistical analysis, generating analytic reports, tables, figures, and slides in support of clinical study and … industry Solid programming background and advanced SAS programming skills required Prior experience in leading studies/projects is required Prior experience in line management (direct reports) is a plus CDISC experience in SDTM/ADaM/Define.xml standards are required Prior submission experience is highly preferred. Other statistical software knowledge is a plus (R, S-Plus, WinBugs, etc) Programming skills More ❯

work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent knowledge of CDISC SDTM and ADaM implementation guidelines working independently in this area; producing, reviewing and updating complex dataset specifications (including efficacy); creating and debugging complex macros; reviewing Statistical Analysis Plans (SAPs), including … industry Good awareness of clinical trial issues, design, and implementation Experience of regulatory submissions and associated industry guidance Familiarity with GCP and regulatory requirements Knowledge of SDTM and ADaM CDISC standards APPLY NOW With the world's eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for More ❯

deliverables in compliance with regulatory requirements and industry standards. Responsibilities Develop, validate, and maintain SAS and R programs for data analysis, visualization, and reporting of clinical trial data. Generate CDISC SDTM datasets, analysis datasets (ADaM), tables, listings, and figures (TLFs) for clinical trial reports and regulatory submissions. Should be able to write the SDTM specifications and ADaM specifications based on … the SAP and TFL shells. Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory guidelines. Collaborate with statisticians and clinical teams to interpret and implement statistical analysis plans. Provide technical leadership and mentor junior programmers in best practices for statistical programming. Perform quality control (QC) checks on programming deliverables to ensure accuracy and consistency. Participate in the development of standard … in SAS programming with experience in Advanced SAS, SAS/STAT, and SAS Macro development. Strong experience in R programming for statistical analysis and visualization. Hands-on experience with CDISC standards (SDTM, ADaM) and regulatory submission requirements. Solid understanding of clinical trial design, statistical methods, and regulatory guidelines (FDA, EMA, ICH). Experience working with clinical data from Phase I More ❯