SUMMARY

• Confidential has over Seven years of industrial experience working wif SAS and SAS tools emphasizing on analysis, development, design, testing and implementation of various projects for Pharmaceutical, Finance, Biotechnology Industries & Clinical Trials.
• She has sound experience in BASE SAS, SAS/GRAPH, SAS/ODS, SAS/MACROS, SAS/ACCESS and SAS/STAT in Windows environments.
• She has developed tables, graphs and listings for Clinical Study Reports by conducting, documenting and reporting in compliance wif 21 Code of Federal Regulations (21CFR) Part 11, FDA and other regulatory submissions to NDA.
• Thorough noledge of SAS Programming including merging SAS Data Sets, Clinical Data Analysis, preparation of Reports, Summaries, Listings, Graphs and Figures using SAS/BASE, SAS/STAT and SAS/GRAPH according to Statistical Analysis Plan, Standard Operating Procedures (SOPs) and departmental guidelines
• Working noledge on SAS Macros for generic coding and reusable modules
• Excellent noledge of data cleaning and manipulation techniques of disorganized and complicated data.
• Knowledge about Relational Database, Oracle 9i/10G & SQL queries
• Good noledge on Software Development Life Cycle (SDLC)
• Developed new or modified existing SAS programs to load data from teh source and create study specific datasets
• Extensive experience in data manipulation and generating customized reports wif SAS data steps and procedures including DATA NULL, PROC DATASETS, PROC FORMAT, PROC CONTENTS, PROC FREQ, PROC TRANSPOSE, PROC TABULATE, PROC GPLOT, PROC GCHART, Proc PRINT, PROC SQL, PROC SUMMARY, PROC REPORT
• Sound noledge in Clinical Data Management, data analysis and generated CRT listings, tables, reports, graphs for FDA submission according to protocol
• Good working noledge of clinical trials data like Demographic (DM), Adverse Events (AE), Subject Visit (SV), Serious Adverse Events (SAE), Laboratory Data (LAB)
• Experience in using SAS to read, write, import and export to another data file formats, including delimited files, Spreadsheet, Microsoft Excel and Access tables
• Familiar wif ICH, GCP, FDA guidelines and Knowledge of industry practices wif CDISC standards, electronic submissions standards and Models including SDTM, ADaM data models
• Familiar wif Phase I, II and III of Clinical Trials during which worked closely wif senior Bio - statisticians and clinical data managers to provide SAS programming in creating SAS datasets, analyzing teh data, generated tables, figures (graphs) and listings (TFL)
• Good understanding of ETL Layer, Business layer & BI architecture

TECHNICAL SKILLS

SAS 9.2: SAS/BASE, SAS/PROCs, SAS/MACROS, SAS/ACCESS, SAS/GRAPHSAS/SQL, SAS/ODS, SAS/REPORT, SAS/STAT, SAS/CONNECT, TRANSPOSE, CONTENTS, IMPORT, EXPORT, SAS/TABULATE SAS PLOT SAS/MEANS

Databases: RDBMS, Oracle 9i/10g, SQL, MS ACCESS

Prog Languages: SAS 9.2, SQL, C, Object Oriented Programming (OOP), HTML

Office Tools: MS-Office 97/2000/03/07/10, MS-Excel, MS-Power Point, MS-Word, MS-Paint, MS-Access, MS-Outlooks, MS-Communicator

Other IT Tools: Notepad, Text pad, Win zip, Adobe reader, PDF Creator, SDLC

Software: Testing- Manual, Requirement Analysis & Support, Report generation techniques, Bug Tracking Tool- Quality Center, Knowledge of Internet applications Etc.

Operating System: UNIX, MS-DOS, Windows 98, XP, Vista, Windows 7

PROFESSIONAL EXPERIENCE

Confidential

SAS Programmer

Responsibilities:

• Worked wif responsibility for Phase-II of Clinical Trials studies and exporting files to FDA
• Created Analysis data sets from Raw Data Sets by importing from various sources.
• Responsible for creating mock up tables and listings for Statistical Analysis Plan(SAP)
• Created Tables, Listings and Graphs using SAS procedures
• Used Output Delivery System (ODS) facility to write custom safety and efficacy reports in PDF, RTF and HTML formats
• Create SDTM datasets from raw data sets
• Used CDISC SDTM to convert teh tabulations in company’s standards to FDA standard tabulations
• Involved in sending files to FDA.
• Data Sets in ADaM format
• Programming of Analysis Data bases (derived data sets) and transfers of data for internal and external clients.
• Programming of database Quality Control (QC) checks.

Environment: SAS/SQL, SAS/MACROS, SAS/BASE, SAS/STAT, SAS/GRAPH, PL/SQL, SPSS Oracle8

Confidential

SAS Programmer

Responsibilities:

• Produced listing, summary, tables using different SAS/reporting tools like Proc Report, Proc tabulation and data null as per teh requirement.
• Generated statistical analysis, tables, listings and graphs for I-III phases of clinical drug trial studies.
• Used SAS for pre-processing data, SQL queries, data analysis, generating reports, graphics, and statistical analyses.
• Developed reports, listings based on SOP, using various Procedures in Base SAS and SAS/Stat for teh phase II, and III trials.
• Developed Macros for performing edit checks, and generating Alert and Error message where ever is needed and prepare SAS data sets for Statistical and analysis and reports generation.
• Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/ Base and SAS/ Macro facility.
• Developed SAS programs ad-hoc reports and edit checks using SAS BASE, STAT, and GRAPH.
• Tested Validation and Derivation procedures and verified teh accuracy of teh data.

Environment: SAS Base 9.2, SAS/Graph, SAS Macro, MS-Excel, MS-Access, SQL, Windows

Confidential

SAS Programmer

Responsibilities:

• Involved in developing, testing, and writing programs and reports in SAS according to specifications as required.
• Prepared analysis datasets for use by statisticians and Senior Programmers. Ensured analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review.
• Designing, building and testing a series of SAS programs for validating and reporting of clinical data from a standardized oracle/ oracle clinical database for drug submission to regulatory authorities.

Environment: SAS Base 9.2, SAS/Base, SAS/STAT, SAS, SQL, SAS/Access, SAS/ODS, SAS/Graph, SAS Macro, MS-Excel, MS-Access, Windows.

Confidential

SAS Programmer

Responsibilities:

• Performed relevant statistical analysis of surveys and economic data captured during Clinical Trials.
• Worked wif different clinical trials data like Demographics (DM), Adverse Event (AE), Serious Adverse Event (SAE), Laboratory (LB) and Physical Examination (PE).
• Performed Data Validation and Data Cleaning on Clinical data using procedures like Proc Freq, Proc Means, and Proc Univariate.
• Used SAS Macros extensively in teh creation of new programs as well as modification of existing programs to improve ease and consistency of results.
• Wrote SQL Queries to check data for different conditions like duplicate values and missing values.
• Integrated wif Clinical, Regulatory and Data Management colleagues to coordinate collection and reporting of clinical studies.

Environment: SAS Base, SAS/STAT, SAS/Graph, SAS Macro, MS-Excel, MS-Access, SQL, Oracle Clinical, Windows.

Confidential

SAS Programmer/Synthesis

Responsibilities:

• Developed and maintained programs in SAS using SAS tools for Windows and UNIX.
• Worked on Phase I and Phase II clinical trials.
• Performed Validation and QC of datasets, tables, listing and graphs.
• Extensive experience wif SAS programming in data step and wif various SAS Procedures in Base SAS and SAS/Stat, including thorough noledge of SAS Macro Language.
• Standardization, Optimization and Scale-up of chemistry reactions as per teh customer requirement on timely basis and discuss teh reports wif respective heads regularly.
• Coordination wif Analytical team for timely reports and interpretation of results to proceed to next step of Synthesis.
• Adherence to safety, GRP & GLP guidelines.
• Assist in orientation and training of junior or new team members of teh project, on teh organization expectations and processes.

Environment: SAS Base, SAS/STAT, SAS/Graph, SAS Macro, MS-Excel, MS-Access, SQL, Oracle Clinical, Windows, SAS/AF, Oracle 8, Clinical Trial.

Confidential

SAS Intern

Responsibilities:

• Extensively used SAS/Base, SAS/SQL, SAS/STAT&SAS/Macros. .
• Validated summary tables, listings, datasets and graphs.
• Used ODS in order to generate PDF, RTF files out of listings and tables being created.
• Extensively used procedures like PROC SQL, PROC SUMMARY, PROC UNIVARIATE, PROC MEANS, PROC TABULATE, PROC GPLOT, PROC FREQ, PROC COMPARE, PROC REPORT, PROC TRANSPOSE and Data null .

Environment: SAS Base, SAS/STAT, SAS/SQL, SAS Macros, SAS/Graph, ODS, Oracle Clinical, MS-Excel, UNIX, and Windows 2000 Server.