5 of 5 Remote CDISC Jobs in the UK

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 ❯

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 ❯

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 ❯