Excellent written and verbal communications skills. Demonstrated experience managing the outsourcing or externalization programming activities in the clinical trials setting (e.g. working with CROs, academic institutions) is preferred. Expert CDISCStandards knowledge. Knowledge of data structures and relevant programming languages for data manipulation and reporting. Including SAS, R and Python. More ❯
Reading, Berkshire, United Kingdom Hybrid / WFH Options
IQVIA Argentina
/or clinical drug development process • Advanced knowledge of computing applications such as Base SAS, SAS Graph and SAS Macro • Language • Advanced knowledge of relevant DataStandards (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 ❯
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 ❯
enablement, though not focused on algorithm development. Strong stakeholder engagement, communication, and change leadership skills. Expertise with modern data stack: cloud platforms, data lakes, FAIR principles, and standards like CDISC, HL7/FHIR Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our More ❯
enablement, though not focused on algorithm development. Strong stakeholder engagement, communication, and change leadership skills. Expertise with modern data stack: cloud platforms, data lakes, FAIR principles, and standards like CDISC, HL7/FHIR Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our More ❯
enablement, though not focused on algorithm development. Strong stakeholder engagement, communication, and change leadership skills. Expertise with modern data stack: cloud platforms, data lakes, FAIR principles, and standards like CDISC, HL7/FHIR Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our More ❯
East London, London, United Kingdom Hybrid / WFH Options
Veramed
your role and expand your skills. Beneficial Experience Knowledge of the clinical drug development process and relevant disease areas. Awareness of industry standards and ICH guidelines. Experience working to CDISC Standards. Excellent time-management and self-management skills for competing priorities. Ability to work independently and as part of a collaborative team. If you're passionate about delivering high-quality More ❯
your role and expand your skills. Beneficial Experience Knowledge of the clinical drug development process and relevant disease areas. Awareness of industry standards and ICH guidelines. Experience working to CDISC Standards. Excellent time-management and self-management skills for competing priorities. Ability to work independently and as part of a collaborative team. If you're passionate about delivering high-quality More ❯
City of London, London, United Kingdom Hybrid / WFH Options
Veramed
your role and expand your skills. Beneficial Experience Knowledge of the clinical drug development process and relevant disease areas. Awareness of industry standards and ICH guidelines. Experience working to CDISC Standards. Excellent time-management and self-management skills for competing priorities. Ability to work independently and as part of a collaborative team. If you're passionate about delivering high-quality More ❯
Bolton, Greater Manchester, United Kingdom Hybrid / WFH Options
Veramed
your role and expand your skills. Beneficial Experience Knowledge of the clinical drug development process and relevant disease areas. Awareness of industry standards and ICH guidelines. Experience working to CDISC Standards. Excellent time-management and self-management skills for competing priorities. Ability to work independently and as part of a collaborative team. If you're passionate about delivering high-quality More ❯
Bury, Greater Manchester, United Kingdom Hybrid / WFH Options
Veramed
your role and expand your skills. Beneficial Experience Knowledge of the clinical drug development process and relevant disease areas. Awareness of industry standards and ICH guidelines. Experience working to CDISC Standards. Excellent time-management and self-management skills for competing priorities. Ability to work independently and as part of a collaborative team. If you're passionate about delivering high-quality More ❯
Altrincham, Greater Manchester, United Kingdom Hybrid / WFH Options
Veramed
your role and expand your skills. Beneficial Experience Knowledge of the clinical drug development process and relevant disease areas. Awareness of industry standards and ICH guidelines. Experience working to CDISC Standards. Excellent time-management and self-management skills for competing priorities. Ability to work independently and as part of a collaborative team. If you're passionate about delivering high-quality More ❯
Leigh, Greater Manchester, United Kingdom Hybrid / WFH Options
Veramed
your role and expand your skills. Beneficial Experience Knowledge of the clinical drug development process and relevant disease areas. Awareness of industry standards and ICH guidelines. Experience working to CDISC Standards. Excellent time-management and self-management skills for competing priorities. Ability to work independently and as part of a collaborative team. If you're passionate about delivering high-quality More ❯
Leeds, West Yorkshire, United Kingdom Hybrid / WFH Options
Veramed
your role and expand your skills. Beneficial Experience Knowledge of the clinical drug development process and relevant disease areas. Awareness of industry standards and ICH guidelines. Experience working to CDISC Standards. Excellent time-management and self-management skills for competing priorities. Ability to work independently and as part of a collaborative team. If you're passionate about delivering high-quality More ❯
Central London / West End, London, United Kingdom Hybrid / WFH Options
Veramed
your role and expand your skills. Beneficial Experience Knowledge of the clinical drug development process and relevant disease areas. Awareness of industry standards and ICH guidelines. Experience working to CDISC Standards. Excellent time-management and self-management skills for competing priorities. Ability to work independently and as part of a collaborative team. If you're passionate about delivering high-quality More ❯
Ashton-Under-Lyne, Greater Manchester, United Kingdom Hybrid / WFH Options
Veramed
your role and expand your skills. Beneficial Experience Knowledge of the clinical drug development process and relevant disease areas. Awareness of industry standards and ICH guidelines. Experience working to CDISC Standards. Excellent time-management and self-management skills for competing priorities. Ability to work independently and as part of a collaborative team. If you're passionate about delivering high-quality 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 CDISCstandards 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 dataMore ❯
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 CDISCstandards 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 ❯
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 CDISCstandards such as SDTM You belong here! If your experience and interests match with some of the above, we want you to apply. What you'll focus on Become an More ❯
a Subject Matter Expert. In this role you will Analysis and Reporting Standards Development and Management Develop, manage, and optimize GSK-specific datastandards, aligning with industry benchmarks (e.g., CDISC), regulatory and scientific requirements to define custom standards, and creating supporting documentation in response to business needs. Cross-Functional Collaboration Lead, coordinate and contribute to cross-functional teams - engaging representatives … processes and technologies related to datastandards maintenance and adoption. Leadership and Oversight Provide oversight and guidance to CRO partners, represent the organization in internal and external initiatives (e.g., CDISC, PhUSE), manage matrix teams, and support talent development through coaching, mentoring, appraisals, and workload management. Advocacy and Consultancy Act as a champion for datastandards across the organization, supporting stakeholder … experience, in Life Sciences, Computer Sciences, Mathematics and Physics or equivalent. Proven experience working in pharmaceutical industry/Clinical Trial, Clinical Programming with expertise in industry datastandards (e.g., CDISC) and deep understanding of analysis and reporting requirements for clinical trials. Proven ability to analyse business problems/opportunities within at least one of the data stewardship areas (e.g., asset More ❯
a Subject Matter Expert. In this role you will Analysis and Reporting Standards Development and Management Develop, manage, and optimize GSK-specific datastandards, aligning with industry benchmarks (e.g., CDISC), regulatory and scientific requirements to define custom standards, and creating supporting documentation in response to business needs. Cross-Functional Collaboration Lead, coordinate and contribute to cross-functional teams - engaging representatives … processes and technologies related to datastandards maintenance and adoption. Leadership and Oversight Provide oversight and guidance to CRO partners, represent the organization in internal and external initiatives (e.g., CDISC, PhUSE), manage matrix teams, and support talent development through coaching, mentoring, appraisals, and workload management. Advocacy and Consultancy Act as a champion for datastandards across the organization, supporting stakeholder … experience, in Life Sciences, Computer Sciences, Mathematics and Physics or equivalent. Proven experience working in pharmaceutical industry/Clinical Trial, Clinical Programming with expertise in industry datastandards (e.g., CDISC) and deep understanding of analysis and reporting requirements for clinical trials. Proven ability to analyse business problems/opportunities within at least one of the data stewardship areas (e.g., asset More ❯
e.g., SAS, R and R Shiny Framework) in a clinicaldata environment across multiple therapeutic areas, thorough understanding of relational databases and their correlation to submission-ready database structure (CDISCdata structure requirements). Demonstrated programming experience and proficiency with R, R Shiny, tidyverse packages and R Markdown in building advanced R packages and modular Shiny apps (or other development … stack). Excellent knowledge of Good Programming Practices and CDISC standards. Ability to perform, coordinate and oversee the preparation, execution, reporting and documentation of all programming deliverables of a project, with minimal supervision. Strong project management skills. Excellent written and verbal communication skills in English, with the ability to work as part of a global team. 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 clinicaldatastandards (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 CDISCdata 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 ❯