1 to 25 of 71 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 ❯

Senior Backend Software Engineer (C# .NET Core) - Revolutionise Healthcare with REST API Design! Are you ready to make a monumental impact in the healthcare industry? We're looking for a Senior/Lead Backend Software Engineer with a strong focus More ❯

Graph). Familiarity with Containerization such as Docker and EKS/Kubernetes. Familiarity with one or more RnD research process and associated regulatory requirements. Exposure to healthcare data standards (CDISC, HL7, FHIR, SNOMED CT, OMOP, DICOM). Exposure to big data technologies and handling. Knowledge of machine learning operations (MLOps) and model deployment. Strong problem-solving and analytical abilities. Excellent More ❯

in which you will be expected to produce both datasets and outputs. Key responsibilities will include: · Writing SAS programs to create analysis datasets, tables, listings, and figures. · Adhere to CDISC standards for data management and analysis, including SDTM (Study Data Tabulation Model) and ADaM (ADAM Data Model). · Deliver all required outputs to agreed timelines and quality, (e.g., analysis datasets … outsourced to CROs, ensuring that their performance meets the agreed quality. Required Knowledge · 3+ years of experience in clinical trial SAS programming. · Demonstrated knowledge of and experience in applying CDISC standards. · Self-starter with the ability to work within a Biostatistics team. Skills and Abilities · Proficiency with SAS programming and SAS macro code development required along with a good understanding More ❯

/or clinical drug development process Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro Language Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM) Join IQVIA to see where your skills can take you Global exposure Variety of therapeutic areas Collaborative and supportive team environment Access to cutting-edge and 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 ❯

in parallel - including Phase II and/or Phase III studies. Experience leading oncology studies and knowledge of RECIST is strongly preferred. Experience with creating and validating analysis datasets (CDISC ADaM standard), and Tables, Listings, and Figures. Pinnacle 21 experience is strongly preferred. Expert knowledge of SAS. Professional leadership skills coupled with exceptional communication skills. Education: Bachelor’s degree required 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 ❯

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 ❯

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 ❯

level team. Review eCRF, discuss data structures and review activities, ensure project-level standardization which allows pooling and efficient CRT production. Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. CSPD and other project-level strategies). Provide and … 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 relationships on individual studies with external associates according to agreed contract and internal business guidance. Act as … deliverables, proven experience in development of advanced MACROs. Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications. Advanced 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 ❯

bias to action and interest in modelling and making things happen Excellent communication skills for collaborating with technical and non-technical team members Bonus: You have experience working with CDISC standards such as SDTM, ADaM and Define-XML What you’ll focus on Data Processing & Transformation Streamline our trial timelines and ensure data integrity, allowing us to handle more complex More ❯

edge gene therapy clinical trial program in ophthalmology. This role involves advanced programming, data management, and process optimization. The ideal candidate will have a strong background in SAS programming, CDISC standards, and clinical trial data analysis. In this role, you will provide expert-level programming support for our gene therapy ophthalmology program, creating and maintaining SAS programs to clean, analyze … and report clinical trial data. Ensuring that all programming and reporting follow CDISC standards, particularly SDTM and ADaM, will be paramount. You will actively contribute to the development and execution of SAS programs to derive analysis datasets, tables, listings, and figures for clinical study reports (CSRs) and regulatory submissions. Leading efforts to ensure data integrity and consistency throughout the clinical … a minimum of 8-10 years of experience in SAS programming within the clinical trials environment, with significant experience in gene therapy and ophthalmology clinical trials. Strong expertise in CDISC SDTM and ADaM standards, including the creation, manipulation, and validation of datasets for regulatory submissions, is essential. Proven expertise in SAS programming for clinical trial data analysis and reporting, deep 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 ❯

/or clinical drug development process • Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro • Language • Advanced knowledge of relevant Data Standards (such as CDISC/ADaM/SDTM) Join IQVIA to see where your skills can take you • Global exposure • Variety of therapeutic areas • Collaborative and supportive team environment • Access to cutting-edge and More ❯

checks and data exploration (e.g. using frequencies, histograms) • Program and QC routine and ad hoc datasets and TFLs (in SAS) following specifications, applying good programming practice • Complete and review CDISC Validation tool reports • Ensure the appropriate standards are being applied and adhered to • Familiarisation with simple statistical techniques (e.g. t-test, ANOVA, regression, standard survival) • Review of project management related More ❯

checks and data exploration (e.g. using frequencies, histograms) • Program and QC routine and ad hoc datasets and TFLs (in SAS) following specifications, applying good programming practice • Complete and review CDISC Validation tool reports • Ensure the appropriate standards are being applied and adhered to • Familiarisation with simple statistical techniques (e.g. t-test, ANOVA, regression, standard survival) • Review of project management related 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 ❯

Statistics, Computer Science, Mathematics, or a related discipline, or a combination of other education with 8+ years of relevant work experience. Experience Requirements: Outsourcing industry experience required. Experience with CDISC data structures, such as SDTM and ADaM. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity More ❯

and maintaining deep expertise in the various data collection tools applied in the clinical trials such as DTAs, Clinical Data Tools such as LSAF and Pinnacle 21, and in CDISC standards 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 ❯

documents such as protocols, SAPs, CRFs, CSRs Authoring, reviewing, and approving study TFL shells and dataset specifications Authoring, validating, and documenting SAS programs Identifying data issues and outliers Reviewing CDISC Validation reports Resolving data and standards issues Staying updated on emerging standards Maintaining proficiency in SAS Ensuring documentation is audit-ready People Management Line management of staff, overseeing performance Coaching More ❯

CRFs, and CSRs Authoring, reviewing, and approving study TFL shells and dataset specifications Authoring, validating, and documenting SAS programs following good programming practices Identifying data issues and outliers Reviewing CDISC Validation reports Resolving data and standards issues or escalating as needed Staying updated on emerging standards and their impact on trials Maintaining SAS proficiency and awareness of developments Managing study More ❯

TFL shells and dataset specifications Authoring, validating, and documenting SAS programs for datasets, TFLs, and macros, following good programming practices Identifying data issues and outliers Completing, reviewing, and approving CDISC Validation reports Resolving data and standards issues or escalating as needed Staying aware of emerging standards and their impact on trials Maintaining proficiency in SAS and staying updated on developments More ❯