24 of 24 Permanent CDISC Jobs in England

/MACRO, SQL and SAS/BASE procedures, SAS/GRAPH and Statistical procedures. Demonstrable knowledge of regulatory requirements (FDA, ICH), such as CDISC, SDTM/ADaM IG etc. Defines and drives the global technical strategy for programming automation, standardization and advanced analytics capabilities within Global Biometry. Identifies and implements ...

Expertise in data cataloging, metadata management, data classification, data governance, or a closely related discipline. Knowledge of clinical and health data standards, such as CDISC SDTM or ADaM and controlled terminology; familiarity with OMOP, HL7 FHIR, HealthDCAT-AP, or DCAT-AP is an advantage. Understanding of EHDS data holder obligations ...

programming Core Skills & Knowledge Strong, proven proficiency in SAS for producing derived analysis datasets and TFLs In-depth understanding of clinical data structures, including CDISC standards (SDTM, ADaM) and relational databases Hands‐on experience with upstream data handling \- multiple data forms, eDC, workflow, and SDTM Ability to deliver downstream outputs ...

settings Strong SAS proficiency (Base/Macro/Stat/Graph); familiarity with R or other languages is a plus Working knowledge of current CDISC standards — CDASH, SDTM, ADaM, define.xml Track record of producing and validating submission‐ready TFLs and datasets, including ad‐hoc analytical requests Experience supporting regulatory submissions ...

Pharmaceutical industry, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job. Knowledge of CDISC requirements. Learn more about our EEO & Accommodations request here. #J-18808-Ljbffr ...

communication, interpersonal, and presentation skills Willingness to travel up to 10%, potentially including international travel Nice to Have Familiarity with data management standards (GCDMP, CDISC, SDTMIG, CDASH, ADaM) Experience working with system integrators for IVRS, medical coding, eSource, CTMS, eTMF, or similar clinical technologies Experience integrating or programming with REST ...

settings Strong SAS proficiency (Base/Macro/Stat/Graph); familiarity with R or other languages is a plus Working knowledge of current CDISC standards CDASH, SDTM, ADaM, define.xml Track record of producing and validating submission-ready TFLs and datasets, including ad hoc analytical requests Experience supporting regulatory submissions ...

progression. Key responsibilities: Lead statistical activities across global clinical trials Contribute to study design, protocols, SAPs, analyses and reporting Support regulatory submissions and ensure CDISC compliance Mentor junior Biostatisticians and Statistical Programmers Collaborate with clinical, programming and data management teams Act as a trusted statistical contact for clients and project ...

data management practices. Experience working with Clinical Data Management and Electronic Data Capture (EDC) systems. Knowledge of Good Clinical Data Management Practices (GCDMP) and CDISC Study Data Tabulation Model (SDTM) standards. Experience within Medical Devices/Pharma/Clinical industry. Strong project and resource management skills with ability to manage ...

Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice • Identify data issues and outliers • Complete, review and approve CDISC Validation tool reports • Identify data and standards issues and resolve or escalate as appropriate • Awareness of emerging standards and associated impact to ongoing and future ...

Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice • Identify data issues and outliers • Complete, review and approve CDISC Validation tool reports • Identify data and standards issues and resolve or escalate as appropriate • Awareness of emerging standards and associated impact to ongoing and future ...

Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice • Identify data issues and outliers • Complete, review and approve CDISC Validation tool reports • Identify data and standards issues and resolve or escalate as appropriate • Awareness of emerging standards and associated impact to ongoing and future ...

Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice • Identify data issues and outliers • Complete, review and approve CDISC Validation tool reports • Identify data and standards issues and resolve or escalate as appropriate • Awareness of emerging standards and associated impact to ongoing and future ...

like Python, SQL, SAS or R Comfortable experimenting with curiosity, potentially through vibe coding experience Version control experience (e.g. Git) Practical working knowledge of CDISC SDTM/ADaM Experience of FDA/MHRA compliance requirements or participating in sponsor audits/regulatory inspections SCDM certification Even ...

Cytel Inc. is seeking a Senior Statistical Programmer to support or lead SAS programming for one or more Phase I-IV clinical trials, leveraging SDTM and ADaM standards. This fully remote role allows you to ...

part of this new program. Position Overview: As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote. Our values ...

Worldwide Clinical Trials is seeking a skilled Statistical Programmer to join our Global Programming team. You will develop and validate CDISC SDTM/ADaM datasets, create TFLs and listings, and contribute to submission-ready packages across multiple studies. You will review study specs, lead programming efforts on medium complexity trials ...

between speed-to-market and regulatory compliance (GxP, 21 CFR Part 11, GDPR, HIPAA). Cultivate strategic partnerships with data providers and standards bodies (CDISC, HL7 FHIR) to accelerate Evinova's product capabilities. Champion a culture of experimentation, intellectual honesty, and continuous learning within your product area and across … founder of a technology company, or as the first product hire at an early-stage start-up. Working knowledge of clinical trial data standards (CDISC SDTM/ADaM, CDASH) and regulatory submission workflows. When we put unexpected teams in the same room, we unleash bold thinking with the power ...

Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards When … serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) When serving as a subject matter expert for CDISC and other ...

execution;HOW - Knowledge & ExperienceKnowledge & Experience (essential):Proficiency in statistical programming package(s), SAS is required;Familiar with Global Clinical Data Interchange Standards Consortium (CDISC);Experience in SDTM and ADaM specification and programming;Experience in reporting and TFL programming.8+ years' programming experience in pharmaceutical/biotech/CRO environment in drug ...

understand/interpret data are the keys to success, and you will have the opportunity to continually grow your knowledge in SAS and CDISC across all phases and multiple therapy areas. What you will do Develop, test and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets ...

type research‐ready and interoperable. Make clinical trial standards possible through import (from REDCap and other commercial EDC/CTMS solutions) and export (to CDISC SDTM) into capabilities investigators, sponsors, and study sites can effectively use. Implement validation and certification of D4L Collect including … Part 11, and EU Annex 11, including computer system validation and audit‐ready release management. Working fluency in clinical data standards, especially CDISC (SDTM, CDASH) at a conceptual level, and a working understanding of HIPAA + GDPR as they apply to clinical trials and real‐world data. Bachelor’s degree ...

making sure they are complete, accurate, and delivered on time. You will configure study structures, repositories, datasets, reporting components, and access in line with CDISC and governance requirements. You will manage role-based access, study configurations, and Git/Azure DevOps resources using approved requests and compliant processes. You will … trial results generation, reporting, and submission processes. You have experience supporting Statistical Computing Environments, including process flows, user access, and Biometrics requirements. You understand CDISC standards, including SDTM and ADaM, and have worked with Tables, Figures, and Listings. You have worked in regulated pharmaceutical environments and understand SDLC, validation, audit ...

trials, collaborating with sponsors and cross‐functional teams to deliver high‐quality analyses in line with regulatory expectations. Strong SAS programming and CDISC SDTM/ADaM expertise are essential, as is the ability to manage projects and communicate clearly with clients and stakeholders. #J-18808-Ljbffr ...