10 of 10 CDISC Jobs in England

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯