19 of 19 CDISC Jobs in the UK

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 ❯

in Health Technology Assessment/HEOR is preferable 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) Experience More ❯

and activities Subject Matter Expertise Participate in initiatives aimed at expanding Data Science and Data Management capability in a designated area of expertise, such as Automation and Artificial Intelligence, CDISC/CDASH, central labs, local labs, ePro, imaging, RWE, etc. by building best practices in processes, tools, templates, or other guidance for the subject area COMPETENCIES Decision Making, Critical thinking More ❯

in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 8 years of SAS programming experience with clinical trial data. • Good working knowledge of CDISC SDTM and ADaM Implementation Guidelines. • Excellent knowledge of regulatory requirements and drug development process. • Excellent organizational skills and verbal/written communication skills. • Ability to work independently as well as 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 ❯

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 ❯

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 ❯

for data exploration and visualization. Application of statistical methodology and concepts in clinical trial analysis. Experience with R-Shiny apps for data exploration. Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs. In-depth understanding of the phases of clinical trials and the drug development process. 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 ❯

resources, representing programming in study or project teams. Review eCRF, data structures, and activities to ensure project standardization for efficient pooling and CRT production. Ensure compliance with standards (e.g., CDISC), assess requirements, and develop programming specifications as part of analysis plans. Provide and implement statistical programming solutions, share knowledge, and act as a problem-solving expert. Ensure timely and quality … quality control and audit readiness of programming deliverables, ensuring accuracy and reliability of analysis results. Keep up-to-date with advanced programming software (e.g., SAS) and industry requirements (e.g., CDISC SDTM/ADaM, eCTD, Define.xml), attending functional meetings and trainings. Establish effective working relationships with external associates according to contracts and guidelines. Act as SME or lead process improvement initiatives … industry. Expertise in SAS and development of advanced MACROs within a statistical programming environment. Experience in contributing to analysis plans and developing programming specifications. Knowledge of industry standards including CDISC data structures and development of standard programs. Understanding of regulatory requirements (e.g., GCP, study procedures). Strong communication and negotiation skills, with the ability to work globally and influence others. More ❯

clinical projects, including complex projects. Support the identification of scope changes and potential risks to contractual delivery. Act as support statistical programmer on clinical projects. Specify, program, and validate CDISC SDTM and ADaM datasets. Specify, program, and validate statistical analysis results, including datasets, tables, listings, and figures. Produce and review CDISC documentation. Create and validate randomization lists. Ensure compliance with More ❯

programs, ADaM specifications, analysis (datasets, TLGs) complying with regulatory requirements, departmental SOPs and work practices. Manages and Delivers assignments with good quality and within timelines Provides programming support to CDISC based e-submission. Develop, debug, and enhance SAS programs to support quality control of safety or efficacy derived datasets and TLGs. Implement programming standards and comply with regulatory requirements among … MS Office) Demonstrated ability to work independently and in a team environment. Experience Preferred: Expert level of programming skills and problem resolution in SAS. Expert level of knowledge in CDISC based e-submission (creation of ADaM datasets and associated TLGs in study/project (e.g. ISS/ISE), creation of Bioresearch Monitoring (BIMO) Inspection deliverables). Have solid knowledge of … statistical models used for efficacy data analysis. Company/Industry Related Knowledge: Advanced knowledge of government regulations (such as CDISC and ICH) pertaining to drug development in multiple therapeutic areas. Core essential skill sets candidates must have to be considered for the role: Expert level of programming skills and problem resolution in SAS. Advanced knowledge of government regulations (such as 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 ❯

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 ❯

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 ❯

strategic and operational leadership. Oversee CROs and vendors, ensuring compliance with scope, timelines, quality standards, and regulatory requirements. Develop and execute data collection strategies in alignment with company standards (CDISC SDTM, ICH-GCP). Ensure database quality, submission readiness, and timely delivery of data packages to regulatory authorities. Lead the development and review of Data Management Plans, SOPs, and operational … proven experience in Clinical Data Management within pharma/biotech, including substantial project management leadership. Expert knowledge of ICH-GCP, major health authority regulations (FDA, EMA, PMDA, etc.), and CDISC standards. Proficiency with industry EDC systems (e.g., Medidata Rave, InForm) and related platforms (ePRO, eHR). Demonstrated success in leading cross-functional, global teams in a matrix environment. Strong vendor More ❯

creative thinking, attention to detail and empathy for patients to data management, and use these skills to ensure the highest quality trial outcome Bonus: You have experience working with CDISC standards such as SDTM You have high agency and a bias for action You are passionate and curious about our mission; changing how the healthcare industry operates and how new … top of the trial pipeline by capturing and prioritising new requirements for upcoming trials Data leadership Advise others across the company on the use of data standards such as CDISC SDTM, ADaM, SAS Mentor more junior members of your team What we offer (UK) We believe in rewarding the people who are building the future of clinical research. Financial & Growth More ❯