Summary:

• Over 7 years of professional experience of SAS programming in various Pharmaceuticals, Biotech and Healthcare industries in Data Analysis and Reporting in Phase I to Phase IV Clinical Trials
• Statistical programming related to the design, programming, implementation, maintenance, and validation of Clinical trial information for the submission to the FDA during various phases
• Strong experience in Data mining and extraction data analysis and report writing utilizing SQL SSRS
• Worked on SAS datasets like patient medical data, optimization of sas codes using indexing technique to increase the overall performance
• Responsible for Data extraction mining cleansing from several databases like SQL Server, Oracle and other external files using SAS Miner, SSIS
• Worked with batch files and ran SAS programs using UNIX shell scripts
• In depth knowledge in DATA step, functions, Statements, SAS Macro and having good knowledge of CDISC SDTM and ADaM , ICH, GCP, FDA, ISO guidelines and medical terminologies and coding dictionaries WHO, COSTART, ICD-9/10, MedDRA
• Good programming experience in using Proc Format, Proc Transpose, Proc Print, Proc SQL, Proc Report, Proc Freq, Proc Means, Proc Univariate
• Experienced in producing RTF, HTML and PDF formatted files using SAS/ODS and VBA
• Experience in SAS Administration skills, data warehousing and business intelligence
• Knowledge of creating ISS, ISE files, documents, and analyses necessary to support electronic submissions in formats
• Extensively Worked with Biostatisticians and clinical data managers to provide SAS program that analyze the data, generate reports, tables, listings and graphs
• Excellent communication and interpersonal skills helps contribute to timely completion of project deliverables within provided timeline and have ability to adopt new technologies

• Excellent work ethics, self-motivated, quick learner and the attitude to stick into the active competitive workplace

• Excellent analytical and problem solving skills

Skillset:

• SAS Tools: SAS Versions - 9.1.3, SAS 9.2, 9.3, Base SAS, SAS SQL, SAS MACROS, SAS DM, SAS STAT, SAS GRAPH, SAS ODS, SAS ACCESS, SAS CONNECT, ETS, ANOVA/MANOVA, Others Tools: SPSS, MS Office Suite, Adobe 6.0, Reporting Tools, MS Excel, MS Word, MS Visio, MedRA, WHO drug. Databases: MS-Access v10, SQL server, Oracle.
• Languages: SQL, MatLab 8.1, Java Basic

Projects Summary:

Confidential

SAS Analyst

Responsibilities:

• Cooperated with Data managers and biostatisticians for QA, Statistical Analysis Plan development, analysis and reports using SAS
• Worked on creating reports and data analysis using SSRS, and SSIS
• Extensively used different Base SAS Procedures like Proc Contents, Proc Print, Proc Sort
• Extracted data from relational database Cryology Online Database COLD using SAS/SQL
• Extensively used different SAS/STAT procedures like Proc Means, Proc Summary, etc
• Experience with SAS Macro Language for counting treatment groups and performing statistical functions like FREQ, UNIVARIATE, ANOVA, Proc Sort, Proc Print, and Proc Report
• Performed ad hoc checks and produced reports using SAP based Business Objects
• Developed Macro programs to send SAS procedure output to different destinations, such as HTML, RTF, PDF, and Printer
• Used SAS/ GRAPH, Proc Gplot and Proc Greplay for displaying single and multiple graphs respectively

Environment: SAS/BASE 9.2, SAS DI, SAS/STAT, SAS/ODS, SAS/GRAPH, SAS/REPORT, SAP BO, MS Excel, HTML, SQL server.

Confidential

SAS Programmer

Responsibilities:

• Developed SAS logs word and multiple graphs powerpoint FDA submission files using VBA
• Executed SAS for PK analysis for bioequivalence studies to produce safety datasets
• Used SAS management console for importing data Analyzed data and producing tables and listings using Proc Mixed, Proc Lifetest , Proc Summary, Proc Anova, Proc Ttest
• Performed data cleaning, mining using Procs
• Generated clinical data summary tables/Listings/graphs and reports using SAS
• Used graphical tools to visualize the data such as Proc Sgpanel with ODS graphics using Proc GLM for reporting the findings
• Case report form Tabulation CRT DDS / define.xml using PROC REPORT as per CDISC SDTM standard, Ad Hoc reports with SAS Web Report Studio
• Developed analysis datasets by following CDISC ADaM modules
• Created SAS datasets from Excel, Oracle database using SAS Macros

Environment: SAS/BASE 9.2, SAS/MACRO, SAS/STAT, SAS/ACCESS, SAS/ODS, Oracle.

Confidential

SAS Analyst

Responsibilities:

• Categorized clinical trial data as per CDISC into intervention class, event class, finding class, demographic class
• Reviewed protocol documents, case report forms, annotated CRF, and statistical analysis plans for clinical trials. Created ISS/ISE reports
• Performed PK analysis on metabolism drug, how well it is absorbed, distributed, metabolized in and eliminated from body generated safety and efficacy datasets
• Worked on data extraction with SAS ETL on PC SAS, data analysis, statistical analysis and generated reports, listings and graphs using BASE SAS and SAS procedures such as Regression, Proc Summary, Proc Format, Proc Report, Proc SGplot, and Proc Plot and ODS procedure
• Designed tables, graphs for clinical study reports
• Used SAS/Access to communicate with Excel and Oracle database and VBA for concatenation of all word files
• Maintained the high standard of cGLP /cGCP/GMP and provided input in eCTD structure for programs as per FDA/ICH guidelines

Environment: SAS/BASE 9.2, SAS/STAT, SAS/ODS, SAS/GRAPH, SAS/REPORT, MS Excel, HTML, Oracle.

Confidential

SAS Programmer/ Analyst

Responsibilities:

• Extensively used SAS administration skills for managing and modifying metadata server setup/structure, creating new data sources, data libraries, and user groups
• Produced reports using Proc Means, Proc Transpose, Proc Template and also generated RTF, PDF and HTML reports using ODS
• Produced reports looking into various treatment methods and their effects with SSRS
• Generated statistical tables and listings to summarize clinical trial data using SAS/STAT procedures, SAS Macros, Proc Report and using stored procedures on SAS EG
• Extensively used SAS Macro options such as MPRINT, MLOGIC and SYMBOLGEN to test and debug existing macro programs
• Involved in creating customized reports using DATA NULL for regulatory purposes by FDA
• Involved with electronic submission of report for NDA via XML
• Environment: SAS 9.0/9.1, SAS EG 4.2, SAS/MACRO, SAS/GRAPH, SAS/STAT, SAS/ODS, SQL, HTML.

Confidential

SAS Programmer/ Analyst

Responsibilities:

• Developed Oracle SQL scripts to extract data from warehouse to facilitate content verification
• Generated ISS and ISE reports, design, Code and Reports for handling over the project
• Created SAS customized reports, listing and graphs for regulatory submissions using procedures like PRINT, REPORT, MEANS, FREQ, TABULATE, SQL, UNIVARIATE, ANOVA, CORR, GPLOT and GCHART
• Worked on creating SAS views from tables in oracle database using SAS/Proc SQL
• Used Output Delivery System ODS to create a vast variety of reports both in RTF and HTML

Environment: SAS/BASE 8.2/9.0 SAS/STAT, SAS/ODS, SAS/GRAPH, SAS/REPORT, MS Excel, HTML, Oracle.