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.