Description
SDTM Programmer (CDISC Implementer) 12 Month contract, HomebasedKey Responsibilities:
The CDISC Implementer will work in CDISC Consultancy and Implementation (CCI), a group within the Global Statistical Programming department. 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.
Responsibilities include (but are not limited to):
* 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 urther down the line when timelines become critical
Basic Qualifications:
*Relevant career experience programming in a clinical development environment
* Strong SQL and SAS programming skills with respect to data transformation
* Detailed knowledge of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) standards and the principles on which it is founded
* An understanding of where the process of producing SDTM datasets fits within the overall Global Statistical Programming (GSP) workflow
* Coding to conventions provided by Amgen/CDISC
* Identifying data issues that affect programming decisions or the integrity of results
* SAS Macro development (specification/coding/testing) in accordance with standard practice
* Applying source code control procedures for custom SAS Macro Development
* Hands-on experience on CRF annotation with SDTM mapping
* Experience on managing SDTM controlled terminology
If you are interested in this position, please email an up to date CV or please call .
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