Have experience working in different phases (I-IV) of clinical trials.Extensively used SAS for Statistical Analysis, Reporting, and Data Management. Experienced in NDA and other relevant Submissions to FDA, and EMA.Incorporating CDISC standards on existing data standards – CRF annotations, SDTM & ADaM specifications preparation and mapping programming.Excellent Data manipulation and ad hoc programming skills with defensive programming techniques. Knowledge of SAS Drug Development process.Creation and validation of e-submission requirements to the FDA which involved – creating annotated CRF, SAS transport files (XPT files), SDTM and ADaM define documents.Generating summary tables, listings, and figures (TLFs) using SAS/BASE and STAT Procedures.Creating and implementing SAS Macros.Extensively used SAS ODS facility to create outputs in various file formats and output datasets from various statistical procedures.Experience in Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE).Querying and manipulating data from Oracle database by PROC SQL.Experience in efficient use of SAS macro language techniques likes CALL EXECUTE.Experience in different therapeutic areas (Oncology, Cardiovascular, and Neurology)

 Worked on phase II and II Clinical trials. Extensively supported data management team and biostatistics team. Skilled in extracting, manipulating data, and creating datasets from various sources like Excel, flat files, Oracle database, Access database using PROC IMPORT techniques. Involved in daily management of building SAS datasets and SAS Reports using Base SAS and SAS Macros. Responsible for coding and debugging various programs built as part of development as well as modifying existing programs. Extensively used SAS ODS facility to create customized reports in HTML, PDF, and RTF. Developed SAS programs for Edit checks, validated listings, summary tables and various Adhoc reports for different studies.  Supported in creating SDTM mapping specifications and reviewed them.  Supported in creating ADaM specifications and reviewed them based on ADaM IG, annotated mock up shells, SAP, Protocol and SDTM domains. Created SDTM domains like DM, AE, VS, CM, EX, LB and Oncology specific SDTM domains like TU, TR & RS and validated them. Created and validated ADaM datasets for ADSL, ADAE, ADVS, ADTTE, ADTR, ADEX, ADLB and ADRS. Generated and validated safety tables such as Summary of Demographics, Adverse Events, Lab shift and Vital signs parameter tables, etc. Generated and validated efficacy tables such as Summary of PFS Analysis, Overall Survival Analysis and Change from baseline tables. Generated Plots such as Waterfall Plot, Box Plots, scatter plots and other plots for change from baseline in a certain parameter. Worked on deliverable CSR. Supported submission team in creating Define.XML and in preparation of Reviewers guide. Used OpenCDISC for verifying compliance of datasets with CDISC standards and electronic submissions.