Candidate to develop standard global data review tools, such as patient profiles, data quality checks, exception reports, PD reports, listings and figures for oncology trials.
Ensure timelines and adequate quality of data review reporting deliverables for assigned trials. Follow processes and adhere to Client and project specific standards as well as Health Authority requirements (SOP's, Master Analysis Plan, GCP and Regulatory Guidelines).
Comply with project/study programming standards and specifications following internal guidelines.
Provide input in Specifications, CRF and Data structure.
Participate as required at all meetings, discussions and activities covering aspects of data review reporting on trial level activates. Maintain efficient interfaces with internal and external customers.
Qualifications
At least 2 years of work experience using SAS in the data review, analysis and/or the reporting of pharmaceutical data. Working knowledge of SDTM database design/structures. Knowledge of other data review/statistics software packages like Jreview. SAS software systems experience. Experience in research programming preferred. Knowledge about clinical trials a plus. Ability to perform effectively in team environment and good communications skills required.
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