7 of 7 Remote/Hybrid Permanent CDISC Jobs

understanding of clinical data technologies ((e.g. EDC, clinical data hub, statistical computing environment, metadata management tools, J-Review), data standards such as Clinical Data Interchange Standards (Consortium Study Data Tabulation Model and Analysis Data Model), and regulatory compliance and data governance requirementsFluent written and verbal English essentialBenefits & RewardsAt Novartis ...

specifications and data transfersQualificationsBachelor's Degree in Statistics, maths, health informatics, data analytics, computer science,or life sciences fieldSAS Base Certification required;Experience with CDISC SDTM conversion would be an advantage Excellent analytical, written and oral communication skillsEntry level positions are available for recent graduates. Training in SDTM ...

procedures; exposure to Python is beneficialUnderstanding of database design, data structures, and clinical data workflowsFamiliarity with the pharmaceutical drug development processExperience working with CDISC SDTM standards and domains (e.g., EG, CO, DM, RE, VS, SUPP)Strong analytical, problem-solving, and organizational skillsHigh attention to detail with a commitment to data ...

close-out stages in line with protocol requirements, standard operating procedures (SOPs/PGs), Good Clinical Programming Practices (GXP), Clinical Data Interchange Standards (CDISC) and other applicable sponsor or regulatory requirements.Essential Functions:SAS Pre-lock programming - Deliver and support all pre-database lock SAS programming processes associated with data collection … cleaningData import and integration - Support data import programming and reconciliation activities as neededData transfer programming - Deliver and support raw/CDASH, lab only, CDISC/SDTM or sponsor specified custom data transfersProcess Improvements - Actively participate in process improvement initiativesQuality/timelines - Ensure that data programming delivers quality outputs on time ...

data structures, and ensure program-level standardization for effective pooling and efficient case record tabulation (CRT) production.Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. program-level strategies).Provide … refinement of templates, standards, and governance.Maintain up-to-date advanced knowledge of statistical programming languages (e.g. R, SAS, ) as well as industry requirements (e.g. CDISC, eCTD, Define.xml), act as an expert for advanced analysis, reporting, automation and enterprise-scale workflow optimization, and drive adoption of reusable solutions and modern approaches ...

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 valuesWe believe … master’s degree or above.Study lead experience, preferably juggling multiple projects simultaneously preferred.Strong SAS data manipulation, analysis and reporting skills.Solid experience implementing the latest CDISC SDTM/ADaM standards.Strong QC/validation skills.Good ad-hoc reporting skills. Proficiency in Efficacy analysis.Familiarity with drug development life cycle and experience with ...

requests, 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 coordinate environment … clinical 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 readiness ...