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Overview: 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). Responsibilities: • 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. Only candidates holding a valid EU work permit may apply as sponsorship is not offered. We try our best to respond to every application and you can be sure every single one will be reviewed, however due to the potential high volume of responses should you not hear back within 10 days from your application assume you have not been successful on this occasion. You may leave the list at any time by sending the command SIGNOFF allstat to [log in to unmask], leaving the subject line blank.