8 of 8 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 ...

proficiency (Base/Macro/Stat/Graph); working experience with R or other languages is a strong plus Deep, practical knowledge of current CDISC standards (CDASH, SDTM, ADaM, define.xml) and how to apply them consistently across a programme Track record of leading integrated analyses (ISS/ISE) and delivering ...

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 ...

hands-on experience managing data for clinical trials (e.g., CRF design, query resolution) You have working knowledge of EDC systems and data standards (e.g., CDISC) You have a solid understanding of clinical data types and how they relate to analysis You are able to work independently and prioritize across multiple ...

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 ...

submissions and critical drug development decisions. You will develop, validate, and maintain SAS programs, create SDTM/ADaM datasets, and produce TFLs while ensuring CDISC standards and data integrity across studies. #J-18808-Ljbffr ...

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 ...