SUMMARY

• Around five years of experience in SAS programming with good knowledge of advanced statistical methodologies applied in Pharmaceutical and Biotech industries.
• Expertise in analyzing and reporting various phases Of Clinical Trials using tools like Base SAS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/MACRO, SAS/ACCESS and SAS/ODS in UNIX and Windows environment.
• Experience in providing statistical support for clinical studies, including design of studies, selection of appropriate statistical methodologies and tests, sample size and power calculations, randomization, statistical analyses, and interpretation of results.
• Experience in debugging and testing SAS programs to check and process data, generate graphs, tables and listings in analysis system.
• Individually capable of developing new SAS Programs and/or enhancing existing SAS programs from protocols and SAP’s.
• Experience in Data manipulation and producing reports employing various SAS procedures like PROC SQL, PROC REPORT, PROC TABULATE, PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC SUMMARY, and PROC CONTENTS.
• Hands on experience in SAS programming for importing and exporting huge data sets from Flat files, Excel spreadsheets and external RDBMS (ORACLE) tables using LIBNAME and SQL PASSTHRU facility.
• Extensive use of SAS/ACCESS, SAS/CONNECT to connect to various databases such as development and production database.
• Experience in reviewing case report forms CRF’s/SDTM/ADaM to ensure that the protocol objectives are met and the project standards are maintained.
• Working knowledge of medical terminology in clinical trials, clinical trial methodologies, and software systems development.
• Efficient in maintaining working relationships with clients and internal project members, including data managers, research scientists, and other statistical programmers.
• Experience in developing and maintainingstatistical documentation, including description of statistical methods, SAS programs, results and discussion.
• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.
• Possess a strong ability to adapt and learn new technologies and new business lines rapidly.
• Effective team player with strong communication & interpersonal skills.

TECHNICAL SKILLS

Operating systems: WINDOWS

Web Technologies: HTML, Adobe Dream Weaver

SAS Tools: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Access, SAS/ODS, SAS/Report

Database: Oracle Clinical, SQL Server 2000, PL/SQL and MS Access, RDBMS.

MS Office: Word, Excel, PowerPoint, Access and Outlook

Statistical tools: SAS v 9.x

PROFESSIONAL EXPERIENCE

Confidential, San Mateo, CA

SAS Programmer

Responsibilities:

• Assisted with extracting the external data from various resources into raw datasets forclinicalstudies.
• Created analysis datasets from the raw datasets and developed SAS programs for tables, listings, graphs to create study specific datasets, which were used as source datasets for report generation.
• Extensive experience with processing data using different statements like set, sort, merge and update to prepare final analysis dataset.
• Performed analysis on the datasets using PROC UNIVARIATE, PROC MEANS, PROC FREQ, PROC ANOVA and PROC GLM, RDBMS.
• Extensively involved in creating safety and efficacy tables, listings, and figures.
• Worked with different clinical trials (Phases I - III) data like Demographics, Adverse Event, Laboratory data, ECG and Vitals data.
• Generated summary reports for drug data, adverse events, quality of life questionnaire, laboratory data, and Descriptive statistics for demographic data based on statistical analysis plan and table shells.
• Validated the analysis data sets and tables output by comparing the results to that of source programmer using the statistical procedures like PROC COMPARE, RDBMS, PROC FREQ, or PROC MEANS as well as cross checked related tables manually.
• Used SAS Macros extensively in analysis of standard clinical data and generated reports, graphs, listings, summaries, and tables.
• Provided ad-hoc support for generating tables, reports and listings on per study basis and exception reports on a consolidated and individual study basis.
• Involved in various status update meeting and took lead when required and excellent collaborative skills on working closely with statistical personal and team lead.

Environment: SAS/SQL, SAS/MACROS, SAS/BASE, SAS/STAT, SAS/GRAPH, RDBMS.

Confidential, Sanger, CA

SAS Programmer

Responsibilities:

• Developing SAS programs for reporting Clinical trial results, including creating tables and graphs for statistical analysis and Clinical report writing.
• Worked on Clinical trials data in different therapeutic areas viz., Oncology, Cardiology, Pain Management, Endocrinology, and Central Nervous System etc.
• Developed SAS programs for statistical analysis and data displays working with various SAS products SAS/BASE, SAS/SQL, SAS/STAT, SAS/ETL, SAS/ACCESS and SAS/MACROS etc to develop solutions in UNIX and Windows environment.
• Prepared data listings in postscript (PS) format to support Data Review Meetings for Clinical, studies in Early Development Stage (EDS).
• Have used SAS/ETL for extraction of information and then transforming and loading the information to target.
• Performed time series analysis for prediction using SAS forecasting studio of the change in the meal plan price.
• Programmed to produce data listings using SAS. Converted MS - Word documents and Excel tables into SAS data sets.
• Involved in development and enhancements of SAS Programs.
• Strong experience in SAS Programming and business analysis.
• Extensive install, configure and support experience in SAS/Access, Interface to Oracle, Teradata.
• Successfully used Proc Means to calculate means, standard deviation, sum, median, etc of data
• Successfully created the reports using the ODS/HTML.
• Generated graphs using SAS/GRAPH.
• High level experience in the PERL, used in working with database RDBMS, Graphical User interface development.
• Designed and created SAS datasets from various sources like Excel datasheets, flat files and Oracle, creating reports and files from existing SAS datasets.
• Developed routine SAS Macros to create tables, graphs and listings for Clinical Study Reports and regulatory submissions and maintained existing macros.
• Familiar with data and content migration using SAS migration utility for products that relay on metadata.
• Used PROC UNIVARIATE and SAS/STAT procedures for analyzing the data.
• Used SAS PROC SQL pass through facility to connect to tables and created SAS datasets using various SQL joins such as left join, right join, inner join and full join.
• Used SAS Proc SQL pass through facility to connect to Oracle tables and created SAS datasets using various SQL joins such as left join, right join, inner join and full join.
• Used different SAS procedures in phase III trial including statistical analysis methods.

Environment: SAS V9.3/9.4 on Unix and Windows platform, RDBMS, SAS EG, SAS OLAP Cube Studio, SASWeb Report, Studio, SAS/ACCESS, SAS/CONNECT, SAS/Macro, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/ETL, Excel, Access, E-clinical Works.

Confidential

Jr. Statistical Programmer

Responsibilities:

• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations for ANTI INFECTION/ANTIBIOTICS.
• Performed data extraction from multiple sources like Teradata, Facets.
• Extensive use of SAS, SQL, Teradata by handling complex joins and conditions.
• Proficient in SAS Procedures.
• Automating the existing SAS Code by upgrading the performance and efficiency of the code.
• Extensively used the SET, UPDATE and MERGE statements for creating, updating and merging various SAS data sets.
• Authored SAS programs using macros, SQL for data management.
• Built and presented demos in SAS Visual Analytics using client data.
• Proficient in using Base SAS, SAS EG.
• Created dynamic Macro arrays with data step programs.
• Developed efficient, well - documented, readily comprehensible and modifiable SAS code using SAS/ Base and SAS/ Macro facility.
• Generated reports, tables, graph to identify opportunities and recommended strategies based on analysis of internal and external data sets.
• Reports Generation in PDF and EXCEL.
• Assisting other teams in clarifying their queries if required.

Environment: SAS 9.x SAS/SQL, SAS/MACROS, SAS/BASE, SAS/STAT, SAS/REPORT, SAS/Graph and Windows.