SUMMARY

• Clinical SAS programmer with over 7+ years of experience in analysis, design and development of Clinical Trial projects for Pharmaceutical industry.
• Develop SAS programs to create and validate analysis datasets, listings and summary tables of safety and efficacy data for Phase I - IV clinical trials.
• Expertise in Data Import/Export via SAS Data Steps, using SAS Proc Import, SAS/ACCESS, SAS/SQL and SAS/ODS.
• Extensive hands on experience in programming using BASE SAS, SAS/MACROS, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS/CONNECT, SAS/REPORT, SAS/ ODS in Windows and UNIX environments.
• Proficient in Data Manipulations using SAS data step procedures such as SAS FORMATS/INFORMATS, MERGE, PROC APPEND, PROC SORT, AND PROC TRANSPOSE.
• Good command in producing tables and listings with reporting using SAS procedures such as PROC REPORT, PROC TABULATE.
• Strong expertise using SAS/GRAPH to produce Graph by using SAS procedures PROC GPLOT and PROC GCHART.
• Good understanding of Clinical Trials Research Methodologies. Good knowledge with Federal Regulations (21 CFR Part 11) and other regulatory guidelines and CDISC SDTM standards for regulatory submissions.
• Good knowledge of Clinical Trials Data like Demographic Data, Adverse Events, Serious Adverse Events, Laboratory Data.
• Experience in creating and transporting files using PROC COPY and importing using PROC CIMPORT.
• Thorough Knowledge and experience of Microsoft Office tools like MS Access, MS word, MS PowerPoint, MS Excel.
• Proficient in creating reports in HTML, PDF and RTF formats using SAS/ODS facility.
• Excellent work experience in generating Tables, Listings, and Graphs by following the Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs), and departmental guidelines.
• Excellent communication, interpersonal skills and ability to work in a fast-paced and team environment.
• Self organized in all aspects of work such as keeping and recording regular activities by commenting codes and documenting while doing analysis.
• Self-Starter, Self motivated, good team player, analytical and problem solving skills with ability to interact with individuals at all levels, and meeting deadlines.
• Conflict resolution, strong presentation skills, and ability to adapt in a new environment.

TECHNICAL SKILLS

Statistical Packages: SAS

SAS Tools: SASV8/9.1/9.2, SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPHS, SAS/SQL, SAS/ACCESS, SAS/CONNECT SAS/REPORTS, SAS/ODS.

Operating Systems: Windows 98/2000, Windows XP, Windows 7

Databases: SQL server, Oracle and MS Access

Office Tools: MS Word, Excel, Access, PowerPoint.

PROFESSIONAL EXPERIENCE

Confidential, Minneapolis, MN

Sr Clinical SAS Programmer

Responsibilities:

• Applied CDISC standards on clinical trial data for converting raw datasets to SDTM datasets with of mapping documents prepared by following SDTMIG.
• Experience in creating Analysis datasets (ADAM).
• Worked in Phases of clinical trials for heart diseases and diabetes.
• Designed and implemented statistical reporting processes for clinical data analysis.
• Extensively used SAS/Macro facility to provide reusable programs that can be conveniently used time to time and created tables, listing and graphical reports.
• Generated output files in text format, HTML & PDF format using SAS ODS.
• Created SAS transport (.xpt) files and converted the Transport files into SAS Data Sets.
• Used SAS/ACCESS to extract data from Oracle and other relational databases for analysis.
• Developed reports using PROC REPORT, PROC TABULATE and DATA NULL .
• Designed flow charts indicating the input datasets and the techniques that would be used (sort, merge, append) to get the desired output.
• Data Analysis and graphical presentation for various summary reports using Base SAS and SAS/Graph facility.
• Created CRT (Case Report Tabulations) datasets using CDISC standards for submissions to the FDA.
• Performed data validation on the data sets and deleted repeated values using conditional data steps such as IF-THEN statements.
• Good working knowledge of Clinical Trials data like Demographic data, Discrepancy data, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data (Lab data), Physical and Vital Signs and Audit trials.
• Established and maintained a sound working relationship and effective communication within (worked with) Bio-Statistics and Statistical Reporting and Clinical Research and Database personnel.

ENVIRONMENT: SAS/BASE, SAS/SQL, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS/ODS, ORACLE, Windows, Excel, SQL.

Confidential, New Brunswick, NJ

Sr. Clinical SAS Programmer

Responsibilities:

• Worked in phase II & III where largely involved in safety and efficacy data analysis.
• Importing the data from Oracle Clinical database to SAS.
• Reviewed and analyze source (raw) data and related study documentation under the supervision of a Manager.
• Provide different statistical analysis using descriptive statistics as per the requirement of project.
• Experience in developing, designing and or quality check CDISC/SDTM domains
• Involved in development and enhancement of SAS programmer and macros for analyzing clinical data.
• Design, develop, and modify SAS programs to store, analyze and evaluate clinical data.
• Generated different types of tables as per CDISC standards.
• Created different types of summery tables and listings tables using PROC MEANS, PROC TABULATE, PROC REPORT.
• Performed different type of data manipulation by MERGE, SET and PROC SQL.
• Develop SAS macros for reusability and to minimize data processing period.
• Involved in doing edit checks, validation of Analysis datasets, Tables & Listings. Involved in conversion of legacy data to CDISC/SDTM Datasets.
• Execute Quality Assurance procedures of other programmers’ work, cross-validation of SAS programs, and debug complex programming code by using DATA and PROC statement.
• Created new datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort, Update, and conditional statements
• Modified macros for report generation using SAS Macros as per the requirements
• Extensively used Data Null and SAS procedures such as Print, Report, Tabulate, Freq, Means, Summary and Transpose for producing ad-hoc and customized reports and external files
• Read raw data from a various business domains like Oracle, DB2, Excel, flat files into SAS.
• Used LENGTH, INFORMAT to format variables and FORMAT, SPLIT to output data.

ENVIRONMENT: BASE SAS, SAS/GRAPH, SAS/STAT, SAS/MACRO, SAS/SQL, SAS/Access, MS Excel, Windows, Oracle Clinical.

Confidential, Louisville, CO

Clinical SAS Programmer

Responsibilities:

• Transformed existing raw data into standardized CDISC SDTM/ADaM domain datasets using various SAS procedures.
• Involved in clinical trial studies, data migration/extraction of data from Flat files, SQL Tables and SAS datasets.
• Extracted, validated and generated SAS data sets from Oracle; applied ‘SQL Pass through Facility’.
• Analyzed PhaseI, II and III Clinical Trials.
• Communicated with Statisticians and Bio-Statisticians to discuss about various SAP related issues and made presentations to discuss about various possible changes in it.
• Maintained appropriate study application documentation.
• Used the SAS Macros facility to produce weekly and monthly reports.
• Performed Data Validation and Data Cleaning on Clinical Trial data.
• Created and maintained SAS Datasets that are extracted from an Oracle Clinical Database.
• Created SAS Customized Reports using Data Null technique for FDA regulations.
• Performed SAS programming using techniques as SAS Base, SAS Macro, data manipulation techniques, and statistical procedures (e.g., Proc Means, Proc Freq, Proc Report).
• Arranged dataset values using sorting, appending, and merging transformation.
• Preliminary data validation (clinical data quality checks) is done on the clinical trial data using SAS/SQL.
• Produced data listings, summary tables and graphs for interim and final analyses using different statements/functions/procedure for data manipulation.

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

Confidential, Charlottesville, VA

Clinical SAS Programmer

Responsibilities:

• Extract and validate raw data from Excel file, Access, and Oracle Relational Database by SAS/Base and SAS/Macros.
• Produced quality customized reports by using PROC REPORT and provided descriptive statistics using PROC MEANS, PROC FREQ, and PROC TABULATE
• Created SAS transport files for Electronic Submission
• Developed and maintained general-purpose and ad hoc SAS programs for the validation, Extraction, Presentation, manipulation, analysis, and reporting
• Formatted HTML and RTF reports, using SAS/ODS - output delivery system
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using
• SAS/BASE, SAS/MACROS and SAS/GRAPH, SAS/SQL, SAS/ACCESS
• Retrieve clinical and lab data from Oracle database and generate SAS datasets.
• Developed SAS macros for data cleaning and Reporting and to support routing processing
• Generated graphs - Line chart, Pie chart, Bar charts, component bar charts using Proc GPlot and Proc GChart.

ENVIRONMENT: Base SAS, SAS/Macro, SAS/SQL, SAS/Graphs, SAS/STAT, PROC Reports, MS-EXCEL, Oracle 8i, HTML and UNIX.

Confidential

Clinical SAS Programmer

Responsibilities:

• Produced quality customized reports by using PROC REPORT, SUMMARY and also provided descriptive statistics using PROC Means, Frequency, and Univariate.
• Generated graphs using SAS/GRAPH and SAS Graphics Editor.
• Developed routine SAS macros according to the given specifications.
• Imported/Converted randomization data files from Excel, CSV data files into SAS data sets for analysis.
• Designed flowcharts indicating the input data sets and the techniques that would be used (sorting, merging, etc.) to get the desired output.
• Wrote SAS code for data management and reporting, and performed validation, including testing SAS code.
• Wrote statistical sections of Clinical Study Reports and assisted in preparing integrated Clinical/Statistical reports.

ENVIRONMENT: SAS/BASE,SAS/STAT and Windows