7 of 7 Permanent CDISC Jobs

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 ...

presentation skills Willingness to travel up to 10%, potentially including international travel Nice to Have Knowledge of DBT 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 ...

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 ...

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 ...

biometrics QC of documents with clinical data. Programming support for relevant deliverables, such as Investigator Brochures, publications, US and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation, Reviewer's Guide, TLFs, Statistical Analysis Plans (study specific, ISS, ISE, Exposure-Response). Hands-on programming ...

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 ...

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 ...