Key Accountabilities * Deliver best value and high quality service. * Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed. * Assist in the coordination of project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g. setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation. * Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents. * Use efficient programming techniques to produce derived datasets, tables, figures and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures and data listings. * Check own work in an ongoing way to ensure first-time quality. * Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance. *Proactively participate in quality improvement initiatives. * Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required. * Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas. * Provide relevant training and mentorship to staff and project teams as appropriate. * Assist project teams in the resolution of problems encountered in the conduct of their daily work. * Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request. * Develop mapping specification for data exports in accordance with applicable standards.
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