SUMMARY

• Around 8 years of experience in IT as a SAS Programmer/Analyst with profound experience in Pharmaceutical Industry.
• Expertise in BASE SAS programming, SAS/Macros programming and debugging, experience in the Pharmaceutical and Biotechnology industries involving skills in SAS/BASE, SAS/MACRO, SAS/SQL, SAS/STAT, SAS/REPORT, SAS/TABULATE, SAS/GRAPH, SAS/ACCESS, SAS/AF, SAS/CONNECT, SAS/QC, SAS/ETS, SAS/ODS, SAS/MAINFRAME, SAS BI.
• Good expertise in generating Graphs by employing SAS procedures PROC GPLOT, PROC GCHART and PROC GMAP.
• Thorough knowledge and understanding of Code of Federal Regulations (21CFR) Part 11, compliant Statistical Process Control Systems, International Conference on Harmonization (ICH) guidelines and Good Clinical Practice (GCP), FDA, IND and Coding Dictionaries such as MedDRA, WHODRUG and other regulatory guidelines.
• Excellent experience in Parallel and Cross - Over (esp. Phase I) study designs.
• Ability to handle multiple projects with speed blended accuracy and work independently with minimal supervision.
• Good experience in generating ISS and ISE reports for the NDA submission to FDA.
• Excellent Knowledge in SAS Procedures like Proc Print, Proc freq, Proc means, Proc summary, Proc sort, Proc Univariate, Proc Tabulate, Proc Report, Proc Transpose, Proc SQL, data null for generating reports
• Good Interaction with Clinical Data Management, Statisticians, Medical Writers and Regulatory team members.
• Experience in therapeutic areas Central Nervous System, Oncology, Hematology, Virology, and Epidemiology.
• Extensive experience in Base SAS, SAS/MACROS, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/CONNECT, SAS/ACCESS, SAS/ODS.
• Good understanding of relational databases such as ORACLE, Knowledge of the EDC system, InForm, and underlying data structure
• Comprehensive skills in working with Base SAS, SAS/MACRO in UNIX and Windows environments.
• Skilled in SAS Programming, Macro Facility, Preparing Data, PROCs, Producing Reports, Validating Reports, SAS Formats, Storing and Managing Data in SAS Files.
• Experience and excellent command in producing reports employing various SAS Procedures and handling large databases to perform complex data manipulation using multiples files in SAS data steps.
• Extensive knowledge in data management like Merging, concatenating, interleaving of SAS datasets.
• Skilled in generating reports to communicate key findings and articulate strategic implications using PROC PRINT, PROC REPORT, PROC TABULATE, PROC SUMMARY, PROC MEAN, PROC FREQ,PROC GPLOT, PROC UNIVARIATE, PROC TRANSPOSE, PROC SQL and PROC GCHART etc.
• Proficient in exporting generated outputs to other environments or the web using various SAS method like create delimited, text files, ODBC.
• Generated output files in RTF, HTML, and PDF format using SAS ODS.
• Worked in conjunction with CROs to perform Clinical Data Analysis for Phase I - III Protocols and strong experience in CDISC SDTM standards.
• Experience with complete new Drug & Device release process from IND submission to FDA approval, in compliance with 21CFR Part 11, which includes Clinical Trials (Phases I-IV), preparation of IND, NDA, safety reviews, adverse event report reviews, integrated safety and efficacy summary (ISS & ISE) for FDA submission.
• Experience in using different relational database management systems like DB2, Teradata and Oracle. .
• Strong experience with SDTM mapping and related programming.
• Experience using SQL (including T-SQL, PL/SQL of Stored Procedures, Stored Functions, Views) for simple to complex data manipulation or report generation.
• Fair knowledge of Object oriented concepts, posses working knowledge of Core Java.
• Experience working on different operating systems (Unix, Windows, Linux)
• Experience with regression analysis, correlation analysis and analysis of variance on clinical trial data.
• Created and customized Macros for use in data cleaning, initialization, creation of analysis, datasets and report generation for FDA submissions.
• Experience in creating test scenarios to find errors and confirm programs meet specifications. Program Documentation and Review.
• Thorough Knowledge and experience of Microsoft Office tools like MS Access, MS word, MS PowerPoint, MS Excel, Lotus Notes.
• Excellent communication, analytical, interpersonal, presentation and problem solving skills.
• Efficient UNIX and Shell Scripting skills.
• Experience in handling large volume data.
• Effective team player with excellent Communication & Interpersonal skills and strong leadership qualities.
• Highly motivated and goal achiever individual.

TECHNICAL SKILLS

Statistical Packages: SAS 6.x 8.x 9.x (Base SAS, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/QC, SAS/STATS SAS/IntrNET), SAS BI Tools SAS Enterprise Guide, SAS Data warehouse, ETL Studio, SAS Enterprise Miner, Minitab V14, S-PLUS, four domain models of CDISC.

Web based Tools: HTML/DHTML, CSS, CGI, PERL, Java Script, VBScript, Front Page,Adobe PhotoShop and Dream Weaver.

Languages: C, C++, SQL, PL/SQL, MATLAB (Statistical Toolbox, Signal Processing toolbox, Image processing toolbox), JAVA.

Databases: MS SQL Server 2000/7.0/6.5 , MS Access 2000, DB2,Oracle8i,9i,10g

Platforms: IBM AS/400, Windows 9x/NT/2K/XP, DOS, UNIX, LINUX, Oracle 10g.

Others: MS office, UNIX shell scripting, Lab View, Math CAD, Crystal Reports.

PROFESSIONAL EXPERIENCE

Confidential, Irving, TX

SAS Analyst

Responsibilities:

• Created new and modified existing SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs.
• Extracted raw data from the warehouse and created SAS data sets that are required for the project analysis using SAS/ACCESS and SAS/CONNECT.
• Developed several ad hoc SAS programs to create summaries and listings.
• Customize the existing programs using SAS Macros as per the statistician’s requirements
• Analyzed different drugs sales activity metrics and generated reports and graphical representation of these sales for comparison of different drugs using SAS/GRAPH and SAS/STAT. Used PROC GPLOT to create graphs in SAS.
• Experience in Clinical Data Analysis, Generating Statistical Analysis Files, Lists, Tables, Graphs, Validations, Documentation, FDA Electronic Submissions. Good Experience in Phase I, II, & III Clinical Drug Trials studies.
• Understanding of drug development process - conducting clinical trials, collection (paper CRF, eCRF (EDC, RDC)), analyses and presentation of data
• Generated SAS Customized reports using the DATA NULL and PROC REPORT techniques.
• Involved in pooling of data from multiple studies and generating Tables/Listings/Graphs for Summary of Clinical Safety (SCS) for FDA Submission.
• Understanding of Bio-statistical work flow: Starting from Raw Datasets to creation of submission package i.e., CRT packages.
• Thorough knowledge and understanding of Code of Federal Regulations (21CFR) Part 11, GCP, ICH, FDA and other regulatory guidelines.
• Excellent experience in Parallel and Cross-Over (esp. Phase I) study designs.
• Developed SDTM data mapping and created SDTM datasets per CDISC standards.
• Created TEMPLATES to modify the appearance of the displayed ODS tables using PROC TEMPLATE.
• Extensively used PROC FREQ, PROC TABULATE, PROC MEANS, PROC MACROS, PROC SUMMARY, PROC CONTENTS, PROC COMPARE and PROC UNIVARIATE.
• Performed data analysis on the data sets using PROC MEANS, PROC FREQ, and PROC UNIVARIATE etc.
• Developed summary reports using SAS PROCEDURES like PROC FREQ, PROC UNIVARIATE, PROC SUMMARY, PROC REPORT, PROC MEANS, and PROC TABULATE etc.
• Developed custom reports using Data Null
• Gave significant contribution in modifying or rewriting an entire report section using SAS MACRO, SAS/FUNCTIONS, PROC CONTENT, PROC MEANS, PROC FREQ, PROC TABULATE, PROC REPORT, etc. according to Oracle database format.
• Used ODS statements and PROC TEMPLATE to create reports in style format.
• Used SAS extensively to create ad hoc reports.
• Used SAS Macros, PROC SQL to extract, sort, match test accounts and ODS to HTML, PDF and RTF.

Environment: SAS/BASE, SAS/ACCESS, SAS/CONNECT, SAS/SQL, SAS/STATS, SAS/GRAPH, MS-Excel, MS-Access, ORACLE, HTML, CDISC, Java, Windows XP

Confidential - King of Prussia, PA

SAS Programmer/Analyst

Responsibilities:

• Produced analysis ready datasets using standard set of macro tools and non-standard tools according to the CDISC standards.
• Participated in creation of SDTM datasets and in derivation of ADaM datasets by implementing CDISC Standards. Good command on ODM and Define.XML.
• Extracted and analyzed data from the database using SAS/Access, SAS/SQL PROCEDURES and created SAS datasets.
• Responsible for maintenance and enhancements in reporting systems using SAS/BASE, SAS/MACRO, SAS/STAT, and SAS/GRAPH.
• Participated in direct analysis of data and definition of efficient, cost effective application solutions which support client business processes and functional requirements.
• Performed coding, testing, debugging, documentation, and installation tasks for on-line and batch processes reports in accordance with client specific internal procedures and standards.
• Actively coordinated to develop and maintain SAS codes/programs in a UNIX environment.
• Extract and transform the raw data into analysis dataset in the desired format as per the CDISC standards.
• Experience with FDA/EMEA trial submissions
• Review the protocol, case report forms (CRFs), statistical analysis plan (SAP) and Develop programs to create TLG’s as per the SAP shell.
• Responsible for writing and debugging statistical programming, documented programming procedures and involved in coding
• Developed new or modified SAS programs to load data from the source and create study specific datasets, which are used as source datasets for report generating programs
• Involved in generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) analysis Datasets, Tables, Listing and Graphs for multiple trials.
• Created complex and reusable Macros and extensively used existing macros and developed SAS Programs for Data Cleaning, validation, analysis and Report generation. Tested and debugged existing macros
• Designed tables, listings and graphs for safety and efficacy reports. Collected requirements from statisticians, prepare requirements document, follow up and develop new macros as per statistician’s request
• Used Proc SQL to retrieve, update and report on information from SAS Datasets and databases
• Worked with different CDISC procedures such as SDTM, ADAM, LAB data
• Involved in the validation of codes written by other team members
• Investigated and fixed several issues and proactively suggested new output formats to satisfy the statistician’s requirements. Developed reports using PROC REPORT, PROC TABULATE and DATA NULL
• Developed SAS programs using SAS/BASE, SAS/SQL, SAS/STAT, SAS/ACCESS and SAS/MACROS for statistical analysis and data display.

Environment: UNIX, VI Editor, Base SAS v9.x, SAS/Access, SAS/SQL, FDA/EMEA SAS/Connect, SAS/SQL, SAS/ODS, SAS/MACRO, SAS/GRAPH, SAS/STAT, MS Excel, Oracle 10g, Toad

Confidential - Atlanta, GA

SAS Programmer/Analyst

Responsibilities:

• Extracted data from Access Database using SAS pass through facility.
• Extensive use of PROC IMPORT procedures for data extraction from CSV and output as SAS datasets.
• Provided SAS programming of data listings, graph outputs & statistical tables as part of clinical study reports.
• Created SDTM datasets in accordance to the CDISC SDTM guidelines.
• Created Analysis dataset, and performed validation before report generation.
• Performed analysis on the raw data to determine the quality and validity of the data
• Produced quality customized reports using proc report and also provided descriptive statistics using proc means, proc freq etc.
• Produced Tables, Listings and Graphs for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Extensively worked with data steps.
• Performed Edit checks using Macros.
• Involved in validation and QC.
• Used SAS/Base, SAS/Graph, macros, PROC SQL, PROC FREQ, PROC SUMMARY, PROC MEANS, PROC UNIVARIATE, PROC ANOVA, PROC MIXED, PROC REPORT etc.
• Produced several ad-hoc reports for the clinical studies, as per the specs that are provided by the Statisticians.
• Developed efficient, well documented, readily comprehensible and modifiable SAS code using SAS/BASE and SAS/MACRO facility.
• Worked with different clinical trials data like Demographic, Adverse Event (AE), Serious Adverse Event (SAE), Laboratory and Physical Examination.
• Involved in FDA Submissions to ensure compliance with 21 CFR Part11.
• Worked with web development team in integrating SAS programs, Involved in writing HTML, java programs and Java Script functions.
• Performed quality control checks on tables, listing etc generated by other team members

Environment: SAS/BASE, SAS/ACCESS, SAS/CONNECT, SAS/STAT, SAS/GRAPH, MS-Excel, MS-Access, ORACLE 9i, HTML, Java, Windows XP, Visual Basic

Confidential, Vista, CA

SAS Programmer

Responsibilities:

• Created Analysis Datasets, Summary Tables, Listings and Plots according to the specifications of the study for statistical analysis.
• Modified Tables and Datasets in Phase III study according to the requirements of the statisticians.
• Data validation and quality control check of the displays and datasets according to the different QC levels.
• Preparation of Case Report Tabulation (CRT), Packages and DEFINE.PDF for the analysis datasets using the Annotated CRF’s.
• Generated CRT (Case Report Tabulation) datasets using CDISC standards for FDA regulatory submissions.
• Performed data analysis, coding and implementation in Windows and Unix environments.
• Worked on the summary of clinical data like Demographic, Adverse Events (AE), Serious Adverse Events (SAE), Adverse Events by System Organ Class and Preferred Term, Related Adverse Events and Adverse Events Leading to Discontinuation.
• Extensively worked on PROC REPORT to produce reports for the purpose of validation.
• Involved in problem solving, data analysis, and complex report generations.
• Developed various forms of out puts, RTF, PDF, HTML files using SASODS facility.
• Extracted data from Oracle data base using SQL Pass through facility.
• Used statistical procedures like PROC MEANS, PROC UNIVARIATE, and PROC FREQ for analysis.
• Worked on Ad-hoc requests from studies in other therapeutic areas and provided programming support to the projects.
• Did consistency checks with other programs and displays within a study and with other studies.

Environment: SAS 9.2, SAS/Base, SAS/Access, SAS/Macro, SAS/SQL, SAS/Graph, SAS/STAT,SAS/Connect, PL/SQL, MS Office, UNIX, Windows

Confidential

SAS Programmer/Analyst

Responsibilities:

• Worked with the Statisticians, Data managers to provide SAS programming in analyzing Clinical Trial Data, generating final study reports, tables, listings and graphs.
• Created and edit check programs to find data discrepancies in raw datasets provided by Data Management Group
• Generated tables, listings and graphs according to Protocol and Statistical Analysis Plan (SAP) using PROC MEANS, PROC FREQ, PROC TRANSPOSE, PROC REPORT, PROC GCHART and PROC GPLOT Procedures.
• Created SAS customized Reports using the Data Null technique.
• Used SAS/STAT procedures such as UNIVARIATE, FREQ, and MEANS were used to carry out analyses
• Responsible for performing queries to generate reports from the results
• Used SASODS to produce HTML, PDF and RTF format files.
• Involved in generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) analysis Datasets, Tables, Listing and Graphs for phase II to phase III trials.

Environment: SAS, SAS/SQL, SAS/MACROS, SAS/BASE, SAS/ACCESS, Oracle SAS/CONNECT, SAS/STAT, SAS/GRAPH, MS-Excel, MS-Access,SQL, HTML, Java, Windows XP