Programming and validation of SDTM datasets, ADaM datasets and TFL’s. Creation/validation of define.xml, validation of data management related tasks.

Responsible for the programming deliverables within Clinical projects including programming of SDTM datasets, ADaM datasets and TFL’s. Perform QC/Validation of data and output. Training of data managers in SAS/SAS Enterprise Guide. Give support to junior SAS programmers.

Tasks and responsibilities:• Creation of SDTM datasets from raw data.• Creation of analysis datasets for phase I-IV clinical studies and for integrated summaries of efficacy and safety according to pre-defined project/study standards and specifications in collaboration with Clinical Data Manager and Biostatistician.• Provide summaries and tables, listings and graphs for Phase I-IV clinical study reports and for integrated reports of efficacy and safety according to pre-defined project/study standards and specifications. • Perform review, quality control and documentation of the programming and output.• Support Clinical Data Management with programming and process optimization. • Give input to management with regard to process improvements in the daily work; identify new procedures and methodologies to increase the accuracy and efficiency of the sectional processes. • Creation of process guidelines/guidance documents used when creating SDTM datasets and analysis datasets. • Assist in the validation of tools and programs developed and/or implemented in the Biometric Division. • Have a basic knowledge of CDISC standards.• Have a basic knowledge of MedDRA and WHO-Drug Dictionaries• Creation of training plan for new employees, planning and organisation of refresher courses • Super-user in SAS® Enterprise Guide; assisting colleagues in usage when needed

SAS programmer within Pharmaceutical Industry:• Validation of ADaM data sets and output, validation and test of SAS-programs and macros. (SAS Drug Development, PC SAS, MS Excel).• Documentation, programming and validation of macros used for reporting (SAS Drug Development, PC SAS, MS Excel).• Programming and validation of efficacy tables and graphs (parallel-programming, visual validation). (PC SAS, Unix SAS).• Validation and QA of clinical data, user acceptance tests, creation and execution of unit- and integration test plans with corresponding reports. (SAS Drug Development, PC SAS, MS Excel).• Creation / implementation of stored processes for creation of Periodic Safety Update Reports and Line listings. Report content verification, process documentation. (PC SAS, SAS Enterprise Guide, SAS Add-In for MS Office, MS Excel).• Creation of PowerPoint market reports consisting of graphs generated by stored processes using SAS Add-in for MS Office. Support and maintenance of existing graphs and their underlying stored processes, process documentation. Education to/supervision of employees in SAS Enterprise Guide in the in-house development of stored processes generating market graphs (PC SAS, SAS Enterprise Guide, Add-In for MS Office, MS PowerPoint).Non-pharmaceutical projects:• Conversion of a multidimensional database to an OLAP cube, enabling the cube on a information delivery portal (PC SAS, SAS Olap Cube Studio, SAS Information Map Studio, SAS Information Delivery Portal)• Improvement of data quality in marketing data (DataFlux® Data Management Studio, PC SAS, MS Excel)• Classification and coding of invoice content to obtain better financial control (DataFlux® Data Management Studio Classification Manager, PC SAS, MS Excel) • Preparation of training material (including fictive data) for the different components of the SAS Business Intelligence server.

A combination of the safety system manager and clinical data manager presented below.

Responsible for: system implementation, system validation and documentation, client installations, user administration, user support and training, database design and programming, database library administration, support and development of the system used for classifying adverse events and medication.

Responsible for the data management process including data-base setup, data capture and data verification and -validation, query handling, preparation of data management related documents. Participated in the validation of the DBMS application