Summary:

• SAS Programmer with 6+ years of experience with emphasis on data analysis, reporting and validation of various clinical studies in the Pharmaceutical industry and CRO’s
• Extensive experience in BASE SAS, SAS MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, Clinical Data Analysis using Oracle Clinical, Clin-Trial Databases
• Extensive experience in all four phases of Clinical Trials (I- IV).
• Established and maintained libraries of fully documented and validated programs, macros, procedures which are used and recycled whenever possible to support the monitoring and reporting of data from clinical trials.
• Experienced in Clinical Trials Data like Demographic data, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data (Lab data), Physical and Vital Signs etc
• Extensively involved in creation and validation of analysis datasets, Tables, Listings, and Graphs
• Experienced in maintaining the company generated MACROS and updating them whenever needed.
• Knowledge of Case Report Tabulation dataset creation
• Experience in CRF-Annotation, FDA regulations such as CDISC, MedDRA, 21 CFR Part 11, ICH, ICD- 9 codes, and GCP guidelines for other Regulatory Submissions (NDA, including an ISS and ISE).
• Experience in integrating clinical data and produced TLGs for integrated summary of safety and efficacy(ISS/ISE)
• Experienced in ad-hoc programming for clinical data management departments
• Experienced in producing external files and customized reports using SAS Procedures.
• Good team member with excellent communication and presentation skills combined with strong analytical, organizational and problem solving skills.

Education:

Bachelor’s Degree in Pharmacy Confidential.

Technical Skills:

SAS Skills SAS9.1/9.2,SAS V8/V9, SAS/BASE, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/SQL, SAS/ODS, SAS/ASSIST, SAS/CONNECT

Databases Oracle Clinical, MS-Access, Microsoft-SQL

Operating System Windows 9X/2000/XP/VISTA, UNIX

Other SPSS, MS-Office (MS-Excel, MS-Access, MS-Word and MS- Outlook)

Professional Experience:

Confidential NJ Jun 11 – Till date
SAS Programmer/Analyst
Responsibilities:

• Develop SAS programs to produce analysis datasets and reports specified in the SAP
• Analyze the Clinical data for Phase II and Phase III studies.
• Involved in validation, data mapping, data cleaning and data analysis
• Created analysis datasets from raw datasets using Data and Proc steps, Set, Merge, Sort, Formats, SAS Functions and conditional statements.
• Generated Tables, Listings, Graphs and Analysis Datasets using various procedures like Proc Freq, Proc Report, Proc Tabulate, Proc Univariate, Data _null_, and Proc Gplot
• Experienced in validation of Tables, Listings, Graphs and Analysis Datasets using Proc compare
• Experienced in using SAS/STAT procedures like Proc ANOVA, T- test, Proc corr, Proc reg, Proc Life test, Proc phreg
• Extracted, validated and generated SAS data sets from Oracle; applied ‘SQL Pass through Facility’.
• Produced Tables, Listings and Graphs for Integrated Summaries of Efficacy (ISE) and Safety (ISS)
• Developed programs in SAS/Base and SAS/SQL to create efficacy and safety analysis datasets and ISS/ISE tables to support NDA submissions by defining variables, merging datasets and creating derived variables
• Participated in Clinical Data Management by performing edit checks.
• Used and generated several company macros and modified them as and when needed
• Used SAS ODS for generating reports in specific output formats like RTF, PDF, and HTML etc.
• Successfully handled multi-studies/tasks at a time

Environment: SAS 9.1, SAS/BASE, SAS/MACRO, SAS/SQL, SAS/CONNECT, SAS/GRAPH, SAS/ODS, DB2, SQL Server, MS Excel, WINDOWS 2000, UNIX.

Confidential, PA Oct 09 –May 11
SAS Programmer/Analyst
Responsibilities:

• Developed and Created new SAS programs (Base & Macros) based on the requirements and the specifications for analysis datasets and reports.
• Responsible for converting flat files to SAS datasets and to load the data in to the data base
• Responsible for extracting data from the database and used BASE SAS to analyze raw data.
• Extensive use of SAS/ACCESS, SAS/CONNECT to connect to various databases (ORACLE, DB2, SQL SERVER) for development and production
• Extracted data from Oracle Clinical database by using the SQL PASS THRU facility
• Assisted in investigating and applying new SAS programming methods and techniques to enhance current systems by using various SAS macros and standard programming procedures.
• Generated highly customized reports using SAS/MACRO facility, PROC REPORT, PROC TABULATE, DATA _NULL_ and PROC SQL.
• Worked with large data sets and transactional data.
• Involved in data quality checking and documentation.
• Preparation of Programming plan and QC Programming Plan.
• Validate analysis datasets and tables, listings and graphs.

Environment: SAS/BASE, SAS/MACRO, SAS/SQL, SAS/CONNECT, SAS/GRAPH, SAS/ODS, DB2, SQL Server, MS Excel, WINDOWS 2000, UNIX.

Confidential, TX Jan 08 –Sep 09
SAS Programmer/Analyst
Responsibilities:

• Performed statistical analysis, wrote SAS code for creating analysis datasets and generating TLF’s, and performed validation.
• Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/ Base and SAS/ Macro facility.
• Maintained clinical trial data base, accessed various database to gather data, performed a table lookup and translated data values for meaning and readability.
• Downloaded data from Oracle using SQL within SAS for further analysis.
• Responsible for implementation of statistical analysis plans and specification documents
• Supported the research staff for technical and programming help.
• Worked with Bio statistician to analyze the results obtained from various statistical procedures like PROC ANOVA, GLM, and T test, lifetest, Hazards Ratio.
• Identifying and mapping data into specific domains as per the CDISC SDTM
• Created CRT (Case Report Tabulations) datasets using CDISC standards for submissions to the FDA
• Involved in clinical trials programming of tables and listings for reporting on safety and efficacy.
• Produced quality customized reports by using PROC TABULATE, REPORT, and also provided descriptive statistics using PROC Means, Frequency, and Univariate.

Environment: SASv8.2, SAS/BASE, SAS/MACRO, SAS/SQL, SAS/CONNECT, SAS/GRAPH, SAS/ODS, DB2, SQL Server, MS Excel, WINDOWS 2000, UNIX.

Confidential, Mumbai, India Jun 06– Dec 07
SAS Programmer/Analyst
Responsibilities:

• Analyzed the Clinical data for Phase II and Phase III trials using SAS programming
• Experience in writing, editing, validating and debugging code in BASE SAS
• Participated in Clinical Data Management by performing edit checks.
• Used PROC REPORT and DATA _NULL_ technique to generate reports.
• Used SAS /ACCESS to gather data from RDBMS like ORACLE
• Worked closely with various teams involving medical writers, data-managers, clinical monitors
• Developed MACROS to generate tables, listings, and graphs for clinical study reports (CSR) and regulatory submissions.
• Reviewed SAPs and created analysis dataset specifications and mock tables.
• Used SAS/STAT for descriptive statistic analysis, ANOVA, Frequency distributions
• Worked with Biostatisticians to analyze and interpret the results
• Used Proc GPLOT to generate graphs
• Involved in writing edit checks and review listings.
• Data cleaning and creation of raw datasets.

Environment: SAS/BASE, SAS/MACRO, SAS/SQL, SAS/CONNECT, SAS/GRAPH, SAS/ODS, DB2, SQL Server, MS Excel, WINDOWS 2000