Srikala Battula

WORK HISTORY

EDUCATION

SKILLS

ABOUT SRIKALA BATTULA

Extensive use of SAS for the Pharmaceutical Industries and analyzing the clinical trials and generating reports, tables, listings and graphs for internal purpose and for FDA according to 21 CFR Part11.• Expertise in producing a wide variety of tables, graphs and listings and conducting statistical analysis with SAS/Macro, SAS/SQL, SAS/Graph, SAS/Base and SAS/ODS in pharmaceutical industry.• Extensive Programming experience with Data Manipulations SAS Formats/Informats, Merge, Proc Append, Proc Datasets, Proc Transpose, Proc Format, Proc Report, Proc Tabulate, Proc Summary, Proc Means, Proc Freq, Proc Univariate, Proc SQL etc. and producing customized reports with Data _Null_.• Experience in importing data from Excel spreadsheets and external RDBMS (Oracle, DB2, and SQL Server) tables using LIBNAME and SQL PASSTHRU facility.• Knowledge in using Statistical Analysis Methods including Proc ANOVA, Proc Glm, Proc Mixed, Proc Plan.• Good working knowledge of the Drug Development Process and worked in Phases I, II and clinical trials studies.• Good working knowledge of Clinical Trials data like Demographic data(DEMOG), Adverse Events(AE), Serious Adverse Events(SAE), Laboratory Data and Vital Signs Data.• Experience in CDISC SDTM in house conversions and thorough understanding of Medra/WHO Drug coding/decoding skills.• Annotated CRF and eCRF to CDISC SDTM standards and ADaM/SDTM Spec Generation.• Thorough experience in CDISC SDTM mapping of clinical trial data to generate SAS compliant datasets as per CDISC standards.• Modified existing SAS Macro programs and created new programs using SAS Macro variables and Macro functions to provide reusable programs that can be conveniently used time to time.