14 of 14 CDISC Jobs in the UK

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 data standards (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 data standards (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 data standards (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 ❯

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 data standards 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 ❯

Leads on process improvement initiatives within Statistical Programming and plays a key role in reviewing and update SOPs. Maintains knowledge of relevant regulatory guidance and requirements, i.e. GCP, MHRA, CDISC etc. Provides in-house training, technical support and mentoring for colleagues. Provides support to Business Development and attends bid defence meetings acting as the Statistical Programming expert. Performs ad hoc … Team Experience of Statistical Programming across Phase 1/II/III Clinical Trials Awareness of Global regulatory environment. Experience of a wide breadth of therapeutic areas. Knowledge of CDISC standards Experience in define-XML production and FDA documentation requirement About Us Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to More ❯

listings) when not provided by CRO. Leads and oversees the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format. Leads and oversees the development of global tools that will increase the efficiency and capacity of the Statistical Programming group. Works closely with clinical study teams to plans … e.g. GCP, ICH). • Extensive experience with statistical programming using the SAS software including development and use of SAS Macros. Strong programming and problem-solving skills. • Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM). • Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities (or equivalent). • Proven ability to work 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 clinical data standards (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 CDISC data 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 ❯

with a wide range of clients to lead Phase II & III studies, program statistical analyses/reports, analyze datasets, tables, figures (or graphs), listings (TFLs), with an emphasis on CDISC ADaM programming. Our team works remotely across multiple countries which provides the flexibility to adjust your schedule as needed. With much collaboration across regions, we still have that small company … experience successfully performing the role of Statistical Programmer, in the clinical research industry Experience leading Phase II and/or Phase III studies Experience creating and validating analysis datasets (CDISC ADaM standard preferred), and Tables, Listings, and Figures (TLF) Strong SAS programming experience Pinnacle 21 experience is strongly preferred Professional leadership skills coupled with exceptional communication skills Bachelor's degree More ❯

as study timelines Strong working knowledge of statistics and statistical software packages Strong SAS programming skills Good working knowledge of statistical concepts Strong working knowledge of data structures (e.g., CDISC SDTM, ADaM), software development lifecycle and their implementation Strong working knowledge of the development and use of standard programs and macros Ability to critically review data and implement corrective action More ❯

regarding database specifications and data transfers Qualifications Bachelor's Degree in Statistics, maths, health informatics, data analytics, computer science,or life sciences field SAS Base Certification required; Experience with CDISC SDTM conversion would be an advantage Excellent analytical, written and oral communication skills Entry level positions are available for recent graduates. Training in SDTM and SAS will be provided. Medpace 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 CDISC standards 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 data More ❯

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 ❯