Description
Role: Senior Programmer / CDISC Consultant, £50 per hour.This role can be fully home based - CW will be working heavily with the US & India
Key Responsibilities:
The CDISC Consultant 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).
The role will provide support for new and ongoing studies and involve close collaboration with other CDISC Consultants and Implementers, Statistical Programmers, Data Standards Librarians, and Data Stewardship Representatives.
Responsibilities include (but are not limited to):
* Perform all CDISC Consultant role responsibilities as prescribed in group Standard Operating Procedures and other organizational guidance
* Participate in CCI and study team meetings to provide expert advice on the application of SDTM implementation guidance to analysis and submission requirements
* Resolve study level mapping issues in a timely manner and escalate global issues for CCI and Biomedical Data Stewardship (BMDS) leadership discussion
* Consult with CDISC Implementers on CRF annotation and SDTM Controlled Terminology Management. Assist in the development of new and complex annotations and terminology.
* Contribute to team and process documentation
* Perform SDTM audits and conformance checks to ensure SDTM compliance
* Assist study teams in defining and developing submission documentation including define.xml and reviewers guide
* Work with CCI Management and other CCI staff to ensure timely deliverables for study milestones
* Support standard process improvement initiatives
Basic Qualifications:
* BA/BS or higher degree in Computer Science, Statistics, Mathematics, Life Sciences, other related scientific subject
* Extensive SDTM consulting experience - conformance assurance, standardization, harmonization, liaising, problem-solving
* In-depth knowledge on SDTM standard - official training from CDISC preferred
* Active member of CDISC Submission Data Standards (SDS) team preferred
* Thorough understanding and experience on data quality and compliance checks - DAT, WebSDM, OpenCDISC
* Working knowledge of ADaM standard desirable
* 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
If you are interested in any of these position, please email an up to date CV or please call .
To find out more about Real please visit www.realstaffing.com/uk">www.realstaffing.com