Graph). Experience with Containerization such as Docker and EKS/Kubernetes. Experience with one or more RnD research process and associated regulatory requirements. Exposure to healthcare datastandards (CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Experience to big data technologies and handling. Knowledge of machine learning operations (MLOps) and model deployment. Strong problem-solving and analytical abilities. Excellent More ❯
Cambridge, Cambridgeshire, UK Hybrid / WFH Options
Jazz Pharmaceuticals
Graph). Experience with Containerization such as Docker and EKS/Kubernetes. Experience with one or more RnD research process and associated regulatory requirements. Exposure to healthcare datastandards (CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Experience to big data technologies and handling. Knowledge of machine learning operations (MLOps) and model deployment. Strong problem-solving and analytical abilities. Excellent More ❯
Graph). Experience with Containerization such as Docker and EKS/Kubernetes. Experience with one or more RnD research process and associated regulatory requirements. Exposure to healthcare datastandards (CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Experience to big data technologies and handling. Knowledge of machine learning operations (MLOps) and model deployment. Strong problem-solving and analytical abilities. Excellent More ❯
Maidenhead, Berkshire, United Kingdom Hybrid / WFH Options
CTI Clinical Trial and Consulting Services
of base SAS, SAS macros, SAS/STAT; demonstrated ability to debug SAS programs Proven professional experience with SDTMs, ADaM datasets (safety and efficacy) and TFLs Solid knowledge of CDISCstandards Submission experience is ideal Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail Business fluency in English - both spoken and More ❯
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: Experience in R Experience with industry datastandards such as CDISC(ODM: CDASH, SDTM, ADaM), HL7 FHIR, OMOP(CDM) etc. Experience with digital clinical trials protocol and Unified Study Definition Model (USDM)Experience in data modelling Closing Date for Applications - July More ❯
will be doing: You’ll lead statistical programming projects, ensuring high-quality, on-time deliverables. This includes developing and validating SDTM and ADaM datasets, performing QC reviews, and ensuring CDISC compliance. You’ll resolve Pinnacle 21 validation issues, review TLFs for consistency, and contribute to regulatory submissions. You'll also create define.xml files, develop and maintain macros, and perform data … + Masters or PH.D in Statistics. 8 years’ experience in clinical trial statistical programming. Excellent knowledge of SAS essential with R advantageous. Good working knowledge of data structures e.g. CDISC, SDTM, ADaM, Comprehension of clinicaldatastandards (CDISC), TLFs, and submission guidelines. What in it for you: The opportunity to be involved in a growing organisation. Enjoy a healthy work More ❯
Trial Team (CTT). Review eCRF, discuss data structures and participate in data review activities as member of the extended CTT. Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements at project-level, review and develop programming specifications as part of the analysis plans. Provide and implement statistical programming solutions; ensure knowledge … programming deliverables as well as accuracy and reliability of statistical analysis results. Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings. Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance As assigned … environment to develop and validate deliverables. Plus R. Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Good knowledge of industry standards including CDISCdata structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures). More ❯
motivated and friendly team as Statistical Programmer (UK Remote) Your responsibilities You program and validate statistical analysis of clinical studies with SAS. You define and program analysis datasets and CDISC SDTM and ADaM datasets in SAS. You are responsible for the quality control of evaluations of clinical studies. You conduct all other programming activities needed during a clinical study. You … experience in programming activities of clinical studies. You have very good programming skills in SAS 9, experience in R would be a benefit. You have gained practical experience with CDISC SDTM and ADaM standards. You have a degree in medical documentation, mathematical biometrics, statistics, mathematics, computer science or a comparable qualification. You are communicative and carry out the required communication More ❯
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 ❯