Professional Experience

• SAS Programmer with more than Six Years of experience in working with SAS emphasizing on analysis, developing, design, testing and implementation of various projects for various Pharmaceutical industries.
• Knowledge on Good Clinical practices (GCP), Good laboratory practices (GLP), Good Manufacturing practices (GMP) and FDA regulations and guidelines in New Drug Development and Clinical Phases, involved in the submission of report to NDA and FDA.
• Experience in providing solutions to clinical data for Clinical Research Phases (I-III) in various therapeutic areas like Cardiovascular, Oncology, and Obesity and Pain.
• Good working knowledge of Clinical Trials data like Demographic data, Adverse Events (AE), Serious Adverse Events (SAE), laboratory data (lab data), physical and vital signs.
• Great command in analyzing the data and generating tables, listings, graphs and reports employing SAS procedure steps like SAS ODS, DATA_NULL_, PROC TABULATE and PROC REPORT according to the standard operating procedures and statistician guidelines.
• Experience in Data manipulations using SAS procedures like PROC APPEND, PROC DATASETS, PROC SORT, PROC TRANSPOSE and SAS DATA STEP FORMATS/INFORMATS, ARRAYS, FUNCTIONS, MERGE and SUBSET.
• Experience in generating HTML and PDF formatted files using SAS/ODS.
• Experience in Ad-hoc Programming for Clinical and Data Management Departments.
• Worked on CDISC and MeDRA Regulated Environment.
• Involved in the process of generating TLG’s for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
• Experienced with SAS Enterprise Guide, BASE/SAS, SAS/SQL, SAS/ACCESS, SAS/GRAPH, SAS/MACRO, SAS/STAT, PROC GPLOT, PROC LIFETEST, PROC REG, and PROC ANOVA in windows environment.
• Excellent analytical, problem solving, communication and interpersonal skills, with ability to interact with individuals at all levels.
• Ability to handle multiple tasks individually as well as in a team.

Technical Skills:

• Operating Systems: Windows 98/XP/2000
• Database Platforms: Clin-Trial, PL/SQL, MS ACCESS 98/2000, SQL Server.
• Statistical Software: SAS/BASE, SAS/STAT, SAS-SQL, SAS/MACRO, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS, SAS-ODS
• Software Packages: MS-Office (Word, Excel, Power point)
• Programming languages: C, C++ , SAS, SQL

Professional Experience

• Analyzed the Clinical data for Phase I - III for different clinical studies such as Anaemia, immunization vaccines.
• Generated Tables, Listings and Graphs using various procedures like Proc Freq, Proc Report, Proc Tabulate, Proc Univariate, Data _null_, and Proc Gplot.
• Experienced in validating programs and in writing competing codes to re-check the statistical values of tables.
• Created SAS Macros and SAS Graphs. Used Proc REPORT to generate reports.
• Successfully designed and implemented statistical reporting processes.
• Performed Data Validation and Data cleaning by Peer-Reviewing.
• Developed routine SAS macros to create tables, and listings for inclusion in Clinical study reports and regulatory submissions.
• Performed Program Documentation on all programs, files and variables for accurate historical record and for future reference.
• Produced Tables, Listings and Graphs for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Produced highly formatted and highly customized reports using Data _Null_.
• Provided SAS programming and statistical support to Statisticians.
• Worked with Data Managers for ensuring the Data Integrity and did Data Cleaning, Data Validation and produced TLG’s as per the requirement of Clinical and Data Management Department.
• Successfully validated TLG’s and CRT’s through independent validation using Proc compare and departmental standard macros.
• Expertise in Integration (Pooling) of datasets from different studies for further analysis.
• Created and maintained SAS Datasets that are extracted from an Oracle Database.
• Successfully handled multi-projects /tasks at a time.

Environment:SAS/BASE, SAS/MACROS, SAS/ODS, SAS/ACCESS,
SAS/CONNECT, SAS/GRAPH, SAS/STAT.

Responsibilities

• Extensively used Base SAS and SAS/STAT.
• Developed reports using Proc report, proc tabulate and Proc Summary.
• Analyzed the Clinical data for Phase I - Phase III forvarious therapeutic area and providing statistical support to Statisticians and Biostatisticians.
• Accessed External Excel files, Stored and Retrieved SAS data sets moving data through multi platforms.
• Creating Tables/Listings/Graphs as per the SAP and protocols.
• Used SAS/STAT for descriptive statistics analysis i.e. ANOVA, Frequency distributions and presented results in Histograms and box-plots.
• Documented the flow charts indicating the input data sets, Sorting and Merging techniques to get the required report.
• Created tables, listing and graphs for Integrated Summaries of Efficacy (ISE) and

Safety (ISS) for multicenter studies.

• Worked on SDTM and ADaM data sets according to CDISC specifications.
• Extensively used Proc Freq, Proc Means, Proc Univariate, Proc Transpose, Proc Mixed, Proc Report, Proc Tabulate, Data _Null_, and Chart procedures in order to ascertain the quality and standards for the code in which changes are made.
• Generated data listings, summary tables and graphics for intermediate and final products

• Modified existing data sets by using the statements like Set, Merge, Update and Conditional statements.
• Assisted seniors and associate programmers in validation, edit checks and data review listings.
• Performed various ad-hoc analyses as per departmental guidelines and requests.
• Assisted statistician in drafting the programming guidelines and SOPs.
• Worked closely with medical writers, data-managers, clinical monitors and fellow programmers.

Environment:SAS/BASE, SAS/MACROS, SAS/ODS, SAS/ACCESS,
SAS/CONNECT, SAS/GRAPH, SAS/STAT, SAS, Oracle.

Responsibilities

• Analyzed the Clinical data for PHASE I and PHASE III forvarious therapeutic areasand providing statistical support to Statisticians and Biostatisticians.
• Extensively used PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC TRANSPOSE, PROC MIXED, PROC REPORT, PROC TABULATE, DATA _NULL_, AND CHARTprocedures in order to ascertain the quality and standards for the code in which changes are made.
• Generated DATA LISTINGS, SUMMARY TABLES AND GRAPHICS for intermediate and final products.
• Performed PROGRAM DOCUMENTATION on all programs, files and variables for accurate historical record and for future reference.
• Produced highly formatted and highly customized reports using DATA _NULL_.
• Worked with Data Managers for ensuring the Data Integrity and did DATA CLEANING, DATA VALIDATION and produced TLGs as per the requirement of Clinical and Data Management Department.
• Created and worked with Clinical Trials data like Demographic data, Discrepancy data, Adverse Events (AE), Serious Adverse Events (SAE), laboratory data (lab data), physical and vital signs.
• Generated Tables, Listings and Graphs for Integrated Summaries of Efficacy (ISE) and Safety (ISS). This INTEGRATION (Pooling) OF DATASETS used for different studies for further analysis.
• Created and maintained SAS Datasets that are extracted from an Oracle Database.
• Successfully handled multi-projects /tasks at a time.
• Communicated with Statistician and Bio-Statistician to discuss about various SAP related issues and made presentation to discuss about various possible changes in it.

Environment: SAS 9.1 CDISC 3.1 SDTM SAS/BASE, SAS/MACROS, PROC SQL, SAS/ACCESS, SAS/ODS, SAS/STAT, SAS/GRPAH, Oracle Clinical.

Responsibilities

• Extensive experience with CLINICAL TRIALS, RANDOMIZATION PROCESS, AUDIT TRIALS, STATISTICAL ANALYSIS, DATA CAPTURE, DATA CLEANING, DATA MANAGEMENT AND REPORTING.
• Created Clinical Trials data like DEMOGRAPHIC DATA, ADVERSE EVENTS (AE), SERIOUS ADVERSE EVENTS (SAE), LABORATORY DATA (LAB DATA), PHYSICAL AND VITAL SIGNS.
• Combined data from datasets to generate tables and listings for Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE) tables to support NDA submissions by defining variables, merging datasets and creating derived variables.
• Created CRT’s (Case Report Tabulations) using CDISC standards (SDTM Model) for submissions to the FDA.
• Familiar with FDA computer systems validation guidelines and electronic records/signature regulations, 21 CFR Part 11.
• Worked with Statistician, Biostatistician, Clinical Data Manager and Medical Writers to provide SAS programming in analyzing the Clinical Trials and generate reports, tables, listings and figures (T/L/F).
• Used SAS/STAT Procedures such as PROC REG, PROC GLM, PROC ANOVA, PROC FREQ, PROC MEANS, and PROC UNIVARIATE.
• Applied PROC SQL, PROC FREQ AND PROC MEANS for data analysis and generating report using PROC TABULATE AND ROC REPORT.
• Used SAS ODS for generating reports in specific output formats like RTF, PDF, and HTML.

• MS, Confidential at Arlington USA