SDTM Programmer

SDTM Programmer Clinical Data Systems Support, Global Development is one of the most competent and diverse team of professionals who are mainly responsible for providing functional and system support to execute clinical trials across Product Development Plan portfolio. The team has strong understanding of Clinical Systems interfaces with endtostart mindset on standardisation of dataflow across systems, Electronic Case Report Form ECRF development using Central Designer and handson experience with Clinical Data Interchange Standards Consortium CDISCconcepts annotated Case Report Form aCRF, Study Data Tabulation Model SDTM mapping, SAS programming, Study Data Review Guideline SDRG etc., to aid CDISC submission which is a mandate from regulatory authorities. The position Your key responsibilities in the job is to design and setup of study database for clinical trials on different sources, Mapping of metadata and clinical data from source systems to CDW Clinical Data Warehouse and finalize SDTM Study Data Tabulation Model deliverables and also review and provide inputs to EDC Electronic Data Capture requirements in relation but not limited to protocol, flow chart, SDTM domains etc, and create trial in CDMS Clinical Data Management System, set up trial database and activate the database in OC Oracle Clinical upon approval from relevant stakeholders, Perform and document UAT User Acceptance testing for checking the quality of OC database and also prepare and submit the request to Control of Standards group to either deviate from an existing standard or use a trial specific element in alignment with Lead SDTM Programmer. Maintain system related documentation and facilitate implementation of business processes introduced by the systems supported by Data Management Systems Standards DaMaSys and finally share better practices on use of standards in alignment with Lead SDTM Programmer and Standards Specialist. Qualifications The below knowledge, skills and experience will be required for the position. M.Sc. B.Sc. in Life Science or comparable degree in Computer Science, Information Technology clinical information management or equivalent qualifications Minimum 4 years of experience in pharmaceutical industry and preferably 23 years of working experience as a statistical programmerExtensive experience with SAS programming Extensive experience with reporting clinical trials, including statistical data handling, analysis and reportingExtensive experience with validation and documentation of programsIndepth knowledge of drug developmentExperience with clinical database technologies, data models and advanced programmingExperience with collaboration across professional and regional bordersRegular experience with communication and presentationsIndepth knowledge of computer systems and ITGood knowledge of GxP and guidelines within drug development