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 and external clients, plan and execute delivery with occasional support of line manager or mentor.• Ensure the maintenance of study documentation as per Worldwide SOP and other procedural documentation.• Contribute to department process improvement including creating and testing standard SAS Macros, maintaining the required validation documentation.• Develop knowledge of SAS (including BASE, GRAPH, MACRO, ODS, SQL) and other software applications (e.g. Excel, Visual Basic, Word). Develop regulatory standards knowledge in computer systems, systems validation, Good Clinical Practice, clinical data management, clinical/statistical reporting and regulatory submission requirements etc.• Assist with internal and external quality audits and inspections.• Perform all activities in compliance with Worldwide and sponsor quality requirements, relevant ICH and regulatory authority standards, e.g. FDA 21 CFR Part 11, General Data Protection Regulation (GDP).

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 e.g. summaries, data listings, study, data sets.- Provide project support to the statistics reporting process through the specification of tables, figures and listings shells.- Provide support in driving system and process improvements to improve the efficiency and quality of clinical study data processing and reporting.- Validate software, in the role of system tester, and test SAS Macros, maintaining the required validation and testing documentation.- Develop knowledge of SAS (including BASE, GRAPH, MACRO, ODS, SQL) other software applications (e.g. Excel, Visual Basic, Word).- Develop regulatory standards knowledge in computer systems, systems validation, Good Clinical Practice, clinical/ statistical reporting and regulatory submission requirements.- Assist with Quality Assurance and Audit requirements