Indu

- Extensive knowledge in clinical data management process and good knowledge of CDISC SDTM .
- Good experience in BASE SAS, SAS MACROS, SAS/SQL
- Good understanding of Clinical Trial Phases, clinical protocols/ CRF's/Annotated CRF's, CDISC, MedDRA, LUDWIG.
- Good experience of writing SDTM mapping specifications.
- Good knowledge over CDISC SDTM (3.2).
- Performed CDISC SDTM mapping of variables to make the raw data compliant with
- SDTM domains using CRF's, raw datasets, DDT's and SDTMIG 3.2 across wide range of therapeutic areas.
- Good experience in Base SAS, SAS/MACRO, SAS/ODS and SAS/SQL.
- Good understanding of Study Protocols and CRFâ??s.
Built Macros and create macro variables using PROC SQL, %LET, CALL SYMPUT, SYMGET, SYMEXIST and DATA _NULL_ to help generate analysis data sets and Create specified structure of TLs.
- Good experience in using SAS functions like SUBSTR, SCAN, PUT, INPUT, INDEX, LENGTH, MOD, ROUND, TRANSLATE, TRANWRD, FIND, FINDC, CAT, CATX, CATS, COALESCE AND COALESCEC etc to manipulate data.
- Good working knowledge of various domains including Demographic Data
(DM),Subject visits (SV), Subject elements (SE), Disposition (DS), Adverse Events(AE), Laboratory Data(LB), Physical examination (PE), Medical History(MH), Vital signs(VS), Concomitant Medication (CM), Subject Characteristics (SC) and Inclusion exclusion criteria (IE) etc.
- Knowledge in CORE SDTM
- Knowledge on Define.XML
- Good communication and presentation skills.