A new contract opportunity for a highly experienced CDISC SDTM Consultant has arisen within a leading Biotechnology company. Working alongside a specialist CDISC Consultancy group within the company’s global Statistical Programming department, you will be responsible for supporting the compliant and consistent adoption of the CDISC Study Data Tabulation Model (SDTM).
• Perform all CDISC SDTM Consultant role responsibilities as per the company’s Standard Operating Procedures and other organisational guidance
• Participate in CDISC SDTM meetings to provide expert advice on the application of company standards and SDTM implementation guidance to company analysis and submission requirements
• Resolve company standards mapping issues in a timely manner and escalate global issues for leadership discussion
• Consult with CDISC Consultants & CDISC Implementers on company standard CRF annotation and SDTM Controlled Terminology Management. Assist in the development of new and complex company standard annotations and terminology
• Contribute to team and process documentation
• Perform company standard audits and conformance checks to ensure compliance
• Support company standard process improvement initiatives
• Support company SDTM controlled terminology Global Librarian activities
• Stay current with all developments in the evolution of CDISC SDTM standards with a particular focus on changes in the SDTM Implementation Guide between published versions
• Liaise with the CDISC Consultancy Group to define the strategy, scope, and timetable regarding the upgrading of studies to use the latest version of CDISC SDTM standards.
Qualifications and Experience:
• BA/BS or higher degree in Computer Science, Statistics, Mathematics, Life Sciences, other related scientific subject
• Pharmaceutical/Biotech industry experience
• 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/compliance checks – DAT, WebSDM, OpenCDISC and CDISC controlled terminology
• 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
For further information please email [log in to unmask] with a copy of your current CV and a summary outlining your relevant experience.
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