SUMMARY

• Confidential has more than 4+ years of experience in SAS programming using SAS 8/8.2/9.1/9.2/9.3 and Data management in Healthcare, Pharmaceutical and Insurance domains.
• Expertise with Clinical Data Management Processes and Clinical Data Management and data analysis
• Rich experiences in SDTM dataset creation based on CDISC standard and quality control
• Proficient in generating Analysis datasets(ADS), tables, listing and graphs with SAS/Macro, SAS/SQL, SAS/Base for clinical study reports
• Hands - on experience in clinical trial conduct and adverse event management. This includes the ability to read and understand medical source documents pertaining to adverse events and the ability to summarize adverse events for Case Report Forms (CRFs) development and review.
• Proficient in maintenance of large data sets and data extraction from different database environments such as Oracle, MS SQL Server and MS Access to and from SAS using PROC ACCESS, SQL pass-through facility and Oracle libname engine.
• Experience in data cleansing and Data Manipulation, ad-hoc reporting and coding utilizing SAS programming skills in SQL and understanding of data management principles, such as joining data sets, data aggregation and sub setting using PROC SQL.
• Hands on experience on the SAS Functions, Statements, Data Set Options and System Options.
• Extensive experience in transforming data imported from disparate data formats into SAS Datasets.
• Expertise in cleaning and resolving data issues and merge data from different sources onto a single integrated dataset.
• Generated various External data files and reports into SAS Dataset SAS Library by using SAS Access, SAS Infile, SAS Import and SAS SQL.
• Good understanding of different coding dictionaries like MedDRA and WHODrug.
• Knowledge of creating all files, documents, and analyses necessary to support electronic submissions in formats - ISS, ISE.
• Proficient in cleaning, importing, managing, manipulating and reporting data into SAS programs and Macros for data quality control, validation and documentations knowledge of statistical analytical skills and experience in efficacy analysis and categorical data analysis
• Extensive knowledge of Microsoft Office Suite, proficient in Advanced Excel
• Solid understanding of pharmaceutical data standard and clinical trial terminologies

TECHNICAL SKILLS

• Windows 9X/NT/2000/XP
• UNIX
• SAS/BASE
• SAS/MACRO
• SAS/SQL
• SAS/GRAPH
• SAS/ACCESS
• SAS/STAT
• SAS/ODS
• SAS/ETL
• C
• C++
• SQL
• PL/SQL
• MATLAB
• HTML
• Oracle 8/9
• MS SQL server
• MS Access
• MS Office 2003 suite.

PROFESSIONAL EXPERIENCE

Confidential, NY

Clinical SAS Programmer

Responsibilities:

• Analyzed the clinical trial data for phases (I-IV) for Oncology study.
• Responsible for providing SAS programming support for Phase II and III clinical trial study design.
• Generated CRTs, TLGs, Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) as per SOP and SAP documents.
• Performed Mapping of datasets created to be following SDTM and ADaM standards.
• Generated define.xml as a part of CRT for FDA submission.
• Developed efficient, well documented, readily comprehensible, modifiable and reusable SAS programs using Base SAS and SASMacros .
• Extracted database files using SQL Pass Through Facility and LIBNAME statements.
• Performed Data Cleaning, Data Validation and Data Documentation on the work developed by other programmers.
• Created ad-hoc reports as per the requirements.
• Generated SAS GRAPHS using Proc Gplot and Proc Gchart and functionalities.
• Generated descriptive and categorical statistical analysis using Proc Means, Proc Univariate, Proc Anova and Proc Glm.
• Calculated p-values using different statistical analysis such as Cochran-Mantel-Haenszel and Wilcoxon signed rank test using Proc Freq and Proc Lifetest respectively.
• Used Proc Import/Proc Export, SAS/ODS and SAS Enterprise guide to generate datasets from external file formats (ASCII, Excel, CSV, Access and PDF) and to convert created datasets into external file formats.
• Performed data manipulation including sorting, merging, concatenating and printing data using PROC SORT, PROC MERGE and PROC PRINT respectively.

Environment: SAS 9.2/9.3, Windows and MS Excel, SAS/Base, SAS/Macro, SAS/SQL, SAS/ODS, SAS/Graph, CSV, PDF, Oracle, SQL database

Confidential, NY

SAS Programmer

Responsibilities:

• Reviewed and Created of specifications, mock tables and listings.
• Responsible for creating programming of TFL using SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO.
• Performed summary statistics analysis on clinical data with PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC LIFETEST, PROC TTEST, PROC LOGISTIC, etc.
• Generated Descriptive reports and analysis, basic listings, summary statistics tables, one-way frequency tables and graphs, and tabular or graphical distribution analysis.
• Extensive experience in the Clinical Development And Reporting System
• Developed validated and documented programs to create TLG's (Tables, Listings and Graphs) as per Statistical Analysis Plan (SAP) using SAS reporting procedures like PROC REPORT, PROC SORT, Graphic procedures like PROC GPLOT and analysis procedures like PROC MEANS and PROC FREQ.
• Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems.
• Computed several ad-hoc reports for safety and efficacy of the clinical studies, as per the specs that are provided by the Statisticians.
• Involved in preparing study results as well as ISS and ISE for FDA submissions using SAS.
• Developed and used SASMacros programs to generate reports, tables and listings for clinical and bio-statistical review.
• Generated Ad-Hoc reports for further analysis using SAS tools.
• Collaborated with Bio Statisticians and representatives from clinical to regulatoryto develop clinical trial reporting systems, tables, patient listings, case report form tabulations and derived datasets.
• Converted clinical trials raw datasets into SDTM datasets based on CDISC standard, and derived specification.
• Created standard data manipulations, mapping, validating and cleaning program.
• In-depth Knowledge in survival analysis, Log-rank test, Hazard Ratio, Kaplan-Meier survival curves, etc.
• Used Output Delivery System (ODS) facility to generate safety and efficacy reports in PDF, RTF and HTML formats.
• Verified (QC) study analysis results, specifications or derived datasets produced by other SAS programmers.

Environment: SAS 9.1/9.2, Windows and MS Excel, SAS/Base, SAS/Macro, SAS/STAT, SAS/SQL, SAS/STAT, SAS/ODS, Oracle, SAS database

Confidential

SAS Programmer

Responsibilities:

• Developed project analysis plans, including table specifications, statistical analyses and report formats.
• Reviewed study Protocols, Annotated Case Report Form (ACRF), and performed validation of clinical trial data to identify illogical data entries.
• Review of specifications, mock tables and listings.
• Performed Statistical Analysis and generated reports using SAS/MACRO, SAS/ODS, Proc Report, Proc Print, Proc Summary, Proc Freq, proc means, proc tabulate and Proc SQL.
• Coordinated, created, and maintained Statistical Programming project documentation.
• Developed SAS programs to manipulate data entry, data cleaning, data coding, data quality control and generated complex listings and reports.
• Performed statistical analysis on health care science database with descriptive statistics, count data analysis using SAS.
• Created and maintained SAS datasets from raw data extracted from databases
• Created SAS reports using the Data Null technique and Proc Report for NDA submission as per FDA regulations and company standards.
• Used PROC COMPARE to conduct quality control checks on files, tables and listing.
• Created transport files for FDA submissions, used MedRA and WHO dictionaries
• Integrate data from wide range of sources including in-house clinical data management systems, labs and contract research organizations and perform data cleaning with data steps and procedure steps
• Performed Data Analysis on the data sets using PROC ANOVA, PROC MEANS, PROC UNIVARIATE, PROC FREQ
• Developed reports using PROC REPORT, PROC TABULATE and DATA NULL
• Use ODS statements and PROC TEMPLATE to create reports in style format.

Environment: SAS8.2/9.1, Windows, SAS/Base, SAS/Macro, SAS/ODS, SAS/Access, SAS/SQL, SAS/STAT, MS Excel.

Confidential

SAS Programmer

Responsibilities:

• Clinical Data Analysis for the therapeutic area- obesity, for a randomized, double blinded studies.
• Performed Data analysis, statistical analysis, generated Reports, Listings and Graphs using SAS Tools - SAS /Base, SAS /Macros, SAS /Reports and SAS/Graph, SAS /SQL, SAS /Access.
• Created SAS reports using the Data Null technique and Proc Report for NDA submission as per FDA regulations and company standards.
• Used PROC COMPARE to conduct quality control checks on files, tables and listing.
• Extensively used CDISC standards to generate SDTM datasets from the raw data.
• Performed Quality check (QC) of the SDTM datasets to ensure that they meet the client specifications.
• Created SAS Transport (.xpt) files and converted the Transport files into SAS Data Sets.
• Extensively used SAS /Macros facility to provide output, combining data sets from different sites, calculating totals & percentages, titles & footnotes and reports generation.
• Generated reports using Procedures such as TABULATE, REPORT, and SUMMARY and provided descriptive statistics using MEANS, FREQ, and UNIVARIATE.
• Generated Graphs, G charts for Adverse Effects caused by the drug in study group.
• Validated programs for logical/syntax errors and applied formats and labels for compliance with CDISC guidelines.
• Extensively used Output Delivery System (ODS) to create RTF, HTML and PDF documents.

Environment: SAS 8/8.2, Base SAS, SAS/ACCESS, SAS/CONNECT, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ODS, SAS/MACROS, MS Access, Windows.