The CDISC Implementer will work within the Global Statistical Programming department where CCI is primarily responsible for supporting the compliant and consistent adoption of the CDISC Study Data Tabulation Model (SDTM) at Amgen. The role will provide support for new and ongoing studies and involve close collaboration with other CDISC Consultants and Implementers, Statistical Programmers, Global Librarians, and Data Stewardship Representatives.
• Develop compliant and consistent CDISC SDTM datasets for all assigned new and ongoing studies.
• Perform all CDISC Implementer role responsibilities as prescribed in group Standard Operating Procedures and other organizational guidance.
• In partnership with CDISC Consultancy perform CRF SDTM annotation and CDISC Controlled Terminology Management.
• Attend CCI staff meetings, raising agenda items, actively participate in discussions, and complete all action items assigned in a timely manner.
• Notifying CCI Management, well in advance, if proposed timelines will be difficult to meet so that Personnel can be reassigned or timelines can be renegotiated with the Study Team if necessary.
• Quickly gain a detailed understanding of the Protocol, Annotated Case Report Form (CRF), Controlled Terminology, and raw datasets (extracted from the CDMS) for all studies assigned.
• Keep abreast of Protocol Amendments, updates to Annotated CRFs, updates to Controlled Terminology, and changes to Study Design impacting the raw datasets – address all changes that have an impact on the development of the SDTM in a timely manner – keep all parties informed of these changes via the Issue Log and follow-up with an email to ensure that everybody is aware of the impending change.
• Follow-up of all SDTM development issues recorded in the Issue Log by the Study Programming Team or other CCI staff in a timely and consistent manner.
• Ensuring that all outgoing communication regarding issues, project status/progress, and changes in implementation standards is clear, concise, accurate, complete and timely.
• Ensuring all incoming communication related to the development of SDTMs is filed for easy reference, reviewed in a timely manner, and acted upon before it creates additional problems further down the line when timelines become critical.
• BA/BS or higher degree in Computer Science, Statistics, Mathematics, Life Sciences, other related scientific subject.
• Strong SQL and SAS programming skills with respect to data transformation.
• Detailed knowledge of CDISC SDTM standards and the principles on which it is founded.
• In-depth knowledge on SDTM standard – official training from CDISC preferred.
• Active member of CDISC Submission Data Standards (SDS) team highly preferred.
• Thorough understanding and experience on data quality and compliance checks – DAT, WebSDM, OpenCDISC.
• Ability to identify data issues that affect programming decisions or the integrity of results.
• Hands-on experience on CRF annotation with SDTM mapping.
• Prior regulatory submission experience with SDTM data and define.xml.
• Effective oral and written communication.
• Good documentation practice.
• Willingness and ability to learn and follow standard processes and procedures in team environment.
• Ability to work proactively and independently.