Sr. CDISC Consultant

Location: Thousand Oaks, CA
Date Posted: 03-12-2018
Day to Day Responsibilities:
  • Lead the development of ADaM data standards  uilk8u klu
  • Provide strategic direction in the adoption and implementation of CDISC ADaM standards with appropriate level of documentation
  • Develop and maintain Data Element Standard (DES) content and ADaM Implementation Guidance and documentation
  • Author/Maintain Amgen developed ADaM Implementation Guides and implementation examples and update metadata repository
  • Ensure that Amgen decisions with respect to ADaM implementation are ADaM-compliant and are in line with industry guidance
  • Maintain current knowledge of all FDA, PMDA or other regulatory agency submission requirements and guidance documents pertaining to analysis datasets, metadata and versions accepted
  • Provide input to continuously improve the management of ADaM standards and metadata
  • Lead a collaborative team of subject matter experts with representation from all TAs
  • Provide a single and consistent adoption and implementation of ADaM standards at Amgen
  • Provide training of Amgen’s implementation of ADaM
  • Provide advice on how new and ongoing projects within Amgen might best begin to use ADaM standards and how/when existing projects might need to up-version
  • Review all changes and additions to SDTM standards due to maintenance or new CDISC versions to ensure that all ADaM input derivations and content based on SDTM are complete, correct and up to date
  • Act as a point of contact to study teams and provide advice as needed on ADaM implementation
  • Review study level ADaM dataset specifications
  • Attend study team meetings
  • Discuss and resolve compliance issues including the dispositioning of Pinnacle 21 issues
  • Interface with statistical programming groups developing automation for define.xml, analysis dataset and TFL production
  • Ensure standard DDTs are kept up to date with GSP standard template and evolving define.xml requirements
  • Ensure that analysis standards can be applied broadly
  • When requested, participate in Amgen internal meetings
  • Provide expert opinion on difficult ADaM implementation issues
  • Explain ADaM concepts and reasons why a certain implementation approach is preferred
  • Represent Amgen on the CDISC ADaM team
  • Position Can Be Onsite in Thousand Oaks or Remote

"This posting is for Contingent Worker, not an FTE"
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