Minja Uskokovic Email & Phone Number

Belgrade, RS

Belgrade, Serbia

• Develop, test and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures and listings (TFL).
• Perform review of the clinical database specification, data transfer agreement/specification, programming related parts of Statistical Analysis plan including TFL shells for low complexity studies with support.
• Develop selected SDTM and ADaM dataset specifications for safety data per the CDISC standard, client's internal standard and regulatory requirement.
• Develop electronic data submission package (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewer's Guide) for low complexity studies.
• Serve as a programming project lead or project lead backup on low complexity studies (e.g. phase I parallel group or crossover design) to distribute and oversee tasks for the programming team, communicate with internal.
• Ensure the maintenance of study documentation as per Worldwide SOP and other procedural documentation.

Belgrade, Serbia

- Develop, test and run SAS programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, CDISC (STDM and ADaM) datasets, tables, figures and listings and their validation.- Ensure the maintenance of documentation e.g. the description of programs and validation.- Extract information from the system.