SUMMARY

• SAS Institute Certified Base SAS Programmer with 7 Years of experience in the area of Clinical Trials Research using SAS/BASE, SAS/MACROS, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/ODS, SAS/ACCESS for generating reports, Tables, Listings, and Graphs.
• Good knowledge on all 4 phases (Phase I, II, III, IV) of clinical trials and their designs including open - labeled, single blinded, double blinded, randomized and crossover studies.
• Thorough experience in analysis of Clinical Trial data and in preparation of SAS datasets/views, Tables, Listings, Graphs, Reports and Summaries according to Protocols and Statistical Analysis Plans(SAP) and departmental guidelines Standard Operating Procedures (SOPs).
• Experience in cleaning and resolving data issues as well as merging data from different sources into a single integrated dataset.
• Experience in Data Manipulation procedures such as SAS Formats / Informats, Merge, Proc Append, Proc Datasets, Proc Sort and Proc Transpose.
• Experience in transforming data imported from disparate data sources into analysis data structures, using SAS functions, options, ODS, array processing, macro facility, and storing and managing data in SAS data files.
• Experienced in creating SDTM datasets (CDISC standards) from raw data, ADAM datasets from SDTM datasets and also involved in the ISS Programming.
• Created SDTM datasets like DM, CM, LB, AE, DS, etc… and ADaM datasets like ADSL, ADLB, ADCM, ADVS, etc…
• Experience in Data management like Merging, concatenating, interleaving of SAS datasets using MERGE and SET statements in DATA step and PROC SQL.
• Experience in Base SAS procedures such as PROC FREQ, MEANS, SUMMARY, UNIVARIATE, FORMAT, IMPORT, REPORT, TABULATE, TRANSPOSE, DATASETS, COPY, PRINT and SQL.
• Proficient in using SAS/ODS for delivering reports in PDF, RTF and HTML files.
• Good understanding of CRTs, SOPs, SAPs and generated reports according to companies requirements.
• Familiar with MedDRA and WHODRUG dictionaries.
• Working with Statisticians to provide SAS programming in analyzing the Clinical Trial Data and implementing statistical methodologies.
• Good command in producing reports employing SAS procedures as Proc Print, Proc Report, Proc Summary, Proc Freq, Proc Means, Proc Univariate, Proc Transpose and Proc SQL.
• Experience in Modifying existing SAS programs and creating new SAS Programs using SAS Macro to improve ease and speed of modifications as well as consistency of results.
• Thorough knowledge and understanding of Code of Federal Regulations (21CFR) Part 11, GCP, ICH, FDA and other regulatory guidelines.
• Excellent analytical, problem solving, communication and interpersonal skills, with ability to interact with individuals at all levels.
• Ability to work effectively with multiple protocols as an individual and also as a part of the team.

TECHNICAL SKILLS

SAS Tools: SAS/BASE, SAS/ACCESS, SAS/CONNECT, SAS/SQL, SAS/REPORTS, SAS/STAT, SAS/MACROS, SAS/ODS and SAS/GRAPH

SAS Process: Print, Means, Tabulate, Univariate, SQL, Report, Freq, Sort, Summary, Format, Import, Export, Transpose, Compare, Gplot and Gchart.

Languages: SQL, PL/SQL and XML

Databases: MS Access and SQL Server

Business Tools: Microsoft Word, Microsoft Excel and Microsoft PowerPoint

Operating Systems: Windows, Enterprise Guide (EG) and UNIX

PROFESSIONAL EXPERIENCE

Confidential, King Of Prussia, PA

SAS Programmer

Responsibilities:

• Involved in the support of Phase II- III clinical trials.
• Created Analysis Datasets (ADaM), Tables, Listings as primary programmer.
• Reviewed SDTM specification and ADaM specification and annotated eCRF according to SDTM variables.
• Created CDISC SDTM datasets.
• Involved in writing the SAS code to help in the process of Quality control by implementing various statistical procedures like Proc Freq, Proc Means, Proc Univariate and other procedures like Proc Summary, Proc Transpose, Proc SQL and Proc Print.
• Created Tables and Listings according to the Statistical Analysis Plan (SAP).
• Modified existing datasets using Set, Merge, Sort, and Update, Formats, Functions and conditional statements.
• Performed verification of SAS-generated outputs (tables and listing) via independent QC programming.
• Worked with Macro’s for generating Tables and Listings.
• Programming and QC’ing the ADHOC Reports on daily basis.
• Attended project team meetings, worked with Bio-Statisticians, Data Managers, and Clinical Research Managers as appropriate.

Environment: SAS/BASE 9.2/9.3, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPHS, SAS/ODS, SAS/ACCESS, SAS/REPORTS, MS Office, EG, UNIX.

Confidential, West Hartford CT

Sr. SAS Programmer

Responsibilities:

• Used SAS/BASE, Macros to develop dynamic SAS programs to extract, validate data for Statistical analysis.
• Developed and designed SAS programs/macros to analyze financial data and to create files, tables, listings, and graphs.
• Extracted data from Oracle, using SQL pass through facility of SAS/ ACCESS, for further analysis.
• Extensively used SAS Data Step functions and descriptive statistical Procedures to process large amounts of customer response and sales data.
• Used SAS procedures like PROC FREQ, PROC MEANS, PROC SORT, PROC PRINT, and PROC TABULATE AND PROC REPORT in order to understand and prepare the data.
• Extensively used PROC Import and PROC Export procedures for importing and exporting PC files and Microsoft office files such as Excel Spreadsheet, Access Tables.
• Developed and maintained standardized SASprograms and Macros for regulatory submission reports.
• Cleaned existing data and converted them into usefulSASDatasets, merged datasets and created reports based on Ad-hoc requirements.
• Generated Ad-hoc reports and browser viewable reports using SAS/ODS. Proficiency in importing different types of external files (Excel, CSV, txt, etc.) into SASlibrary and exporting SASdata sets as external files using Import/Export Wizard, PROC IMPORT, PROC EXPORT and SASDATA steps.
• Design, develop, and test ETL (Extract, Transform and Loading) processes per business requirements, following the development standards and best practices.
• Performed ETL-Extraction/Transformation/Loading, data migration, sampling, data preparation, graphical presentation, statistical analysis, validation, reporting, and documentation.
• Wrote programs in SAS to generate reports, creating RTF, HTML listings, tables and reports using ODS.

Environment: SAS/BASE 9.2, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPHS, SAS/ODS, SAS/ACCESS, MS Office, Windows XP.

Confidential, Horsham, PA

Sr. Statistical Programmer

Responsibilities:

• Used Base SAS, SAS/Stat, SAS/SQL and SAS/Macro to implement statistical analysis procedures and generate reports.
• Involved in Data Cleaning and worked on Edit checks.
• Created dataset according to CDISC-SDTM domain standards.
• Generated statistical summary tables, graphs, and patient data listings for Phase I to Phase III of clinical trials using base SAS procedures such as PROC SUMMARY, PROC TABULATE and SAS GRAPH.
• Debugged and validated programs for logical/syntax errors and applied formats and labels for compliance with CDISC standards.
• Produced quality customized reports by using Data Null, PROC TABULATE, REPORT, and SUMMARY, SQL and also provided descriptive statistics using PROC Means, Frequency, and Univariate.
• Produced output in various formatted files such as Excel sheets, RTF, PDF and HTML using SAS/ODS.
• Responsible for producing Post-text tables, In-text tables, selected patient listings and Lab tables.
• Maintained appropriate study application documentation and provided SAS programming and statistical support to Clinical studies.
• Developed reports using PROC REPORT, PROC TABULATE and DATA NULL .

Environment: SAS/BASE 9.1/9.2, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPHS, SAS/ODS, SAS/ACCESS, SAS/REPORTS, MS Office, Windows XP.

Confidential, Overland Park, KS

Sr. SAS Programmer

Responsibilities:

• Worked with a team of Bio-statisticians and Data Managers for Generating Safety and Efficacy tables across Phase I, II, and III Clinical Studies.
• Experienced in creating SDTM datasets (CDISC standards) from raw data, ADaM datasets from SDTM datasets.
• Involved in QC of SDTM, ADaM data sets, Tables, Listings and Graphs.
• Vast experience in ISS and ISE, worked on FDA Submissions.
• Integrated data from various studies as per SAP to a global standard for Submissions and conducted analysis at compound level.
• Involved in creating various safety and Efficacy Tables for different parallel and extension studies.
• Involved in writing Specifications for integrated datasets as per SAP
• Created Patient Narratives and Subjects mapping for Medical Writing on Ad Hoc basis using template programs and macros.
• Worked with CRO’s to review and finalize Safety and efficacy reports.
• Worked on creating various transport files (.XPT files) for FDA submissions.

Environment: SAS/BASE 9.1, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPHS, SAS/ODS, SAS/ACCESS, SAS/REPORTS, MS Office, Windows XP.

Confidential, Princeton, NJ

Clinical Statistical Programmer

Responsibilities:

• Analysis of clinical data of Phase II and III Clinical trials conducted to evaluate the safety, confirm the effectiveness, comparison with commonly used treatments, and monitor side effects of experimental drugs.
• Designed and implemented statistical reporting processes for clinical data analysis.
• Designing, building and testing in a series of SAS programs for generation of different data sets.
• 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.
• Extensively used SAS/ Macro facility to provide reusable programs that can be conveniently used time to time and created tables, graphs and listing reports.
• Generated various clinical reports, tables and developed data entry validation programs for Phase II and III clinical trial studies.
• Created SAS Customized Reports using the Data Null technique for FDA evaluations.
• Produced quality customized reports by using PROC TABULATE, REPORT, and SUMMARY and also provided descriptive statistics using PROC Means, Freq, and Univariate.
• Generated graphs, gcharts for adverse effects caused by the drug in study group.
• Created and validated macros for the study of Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE) for FDA regulatory submissions.
• Performed Validation and QC of datasets, tables, listing and graphs.
• Created SAS transport file from SAS data sets by using procedures like PROC CPORT and PROC EXPORT.
• Used CDISC Standards like Study Data Tabulation Model (SDTM), ADaM for Drug Development Process and also created Data Tabulation Data Sets.
• Retrieved ORACLE tables with Proc SQL using ‘Pass through Facility’.
• Formatted HTML, PDF and RTF reports, using SAS - output delivery system ODS.

Environment: SAS/BASE 9.1, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPHS, SAS/ODS, SAS/ACCESS, SAS/REPORTS, MS Office, Windows XP.

Confidential

Clinical SAS programmer

Responsibilities:

• Clinical data analysis and creation of reports by extensive use of BaseSAS, SAS/Macro, SAS/SQL and SAS/Graph.
• Involved in the data analysis of safety and efficacy data.
• Used procedures like IMPORT and EXPORT to obtain and load data from MS Excel and MS Access.
• Generated detailed and self-explanatory reports extensively using PROC REPORT.
• Production of Customary Reports and user friendly interfaces.
• Performed statistical modeling including linear and non-linear regression and PROC ANOVA.
• Performed exploratory statistical data analysis using various statistical procedures like PROC FREQ, PROC MEANS, PROC SUMMARY and PROC UNIVARIATE.
• Created datasets and generated reports using PROC TABULATE, PROC REPORT, SAS ARRAYS, PROC SQL and MACROS.
• Formatted HTML, Excel and PDF reports using SAS output delivery system (ODS).
• Worked with statisticians, physicians and performed ad hoc data exploration and standardized reporting.

Environment: SAS/BASE, SAS/MACROS, SAS/GRAPH, SAS/ODS, SAS SQL, SAS/STAT, Windows XP.

Confidential

Clinical SAS programmer

Responsibilities:

• Successfully implemented statistical reporting processes for regular data collection and clinical data analysis. Analyzed Phase I to Phase III Clinical Trials data.
• Proficient in drawing flowcharts indicating the input data sets, sorting and merging techniques to get the required report.
• Developed and maintained programs in SAS using SAS tools for Windows in a user support environment.
• Extensive experience with the SAS programming and in data step and with various SAS Procedures in Base SAS and SAS/STAT, including thorough knowledge of SAS Macro Language.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools such as SAS/Base, SAS/Macros and SAS/Graph, SAS/SQL.
• Program documentation on all programs, files and variables for accurate historical record and for future reference.
• Convert MS-Word documents, MS-Excel, SQL tables into data sets.
• Extensively used SAS/ Macro facility to provide reusable programs that can be conveniently used time to time.
• REPORT, SUMMARY and also provided descriptive statistics using PROC-Means, Frequency and Univariate.
• Formatted HTML and RTF reports, using SAS - output delivery system (ODS).

Environment: SAS/BASE,SAS/STAT, Macros and Windows