Summary:

• Over 7+ years of Experience in developing clinical Statistical Analysis and reporting applications in Pharmaceutical environments using SAS Software.
• Profound Knowledge and Strong experience in Base SAS, SAS/MACRO, SAS ODS, SAS/GRAPH, SAS/SQL, SAS/STAT, SAS/Connect.
• Excellent command in SAS Procedures like Proc Print, Proc Report, Proc Summary, ProcFreq, Proc Tabulate, Proc Mean, ProcUnivariate, Proc Transpose, Proc ANOVA, Proc Mixed ,Proc GLM, ProcCorr, Proc Regression, ProcLifetest and Data_NULL_.
• Worked with statisticians to analyze clinical data and generated tables, listings and graphs for the same generated output files in RTF, HTML, and PDF format using SAS ODS
• Familiar with Code of Federal Regulations (21 CFR Part 11) and electronic submission standards for FDA.
• Strong knowledge in different phases of clinical trials (I-IV), and e-submissions.
• Experience in developing SAS Procedures, Macros, and application for data cleaning, reporting and involved in preparing documentation.
• Worked with Statisticians to provide SAS programming in analyzing the Clinical Trial Data, generate reports, tables, listings and graphs.
• Thorough knowledge of different phases of clinical trials and clinical trials data like Demographic data, Adverse Events data, Laboratory data and Vital signs.
• Very good experience in analyzing Case Report Forms (CRF) data, Clinical Trials, Clinical Data Capture (CDC), Clinical Data Management, Validations and Documentation.
• Have worked closely with the clinical trial data and generating Integrated Summaries Efficacy (ISE) and Integrated Summaries of Safety (ISS) table, listing, graphs.
• Create, manage,design,development, and maintain the programming specifications for the analysis datasets.
• Familiar with FDA regulations, GMP, ICH, GCP and GLP, Knowledge of CDISC, model and SDTM mapping and ADAM experience.
• Involved in validation of tables, listings, graphs and datasets using double programming extensively.
• Ability to work independently as well as in a team with strong analytical, communication interpersonal and presentation skills.

Technical skills:

Professional Experience:

Industry: Confidential, Canton, MI Nov 2011-July 2012
Role: SAS Programmer

Responsibilities:

• As a programmer, was part of a project team that included statisticians, clinical research assistants, data management and system analysts
• Developed routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions.
• Generated Efficacy and Safety tables (Adverse Events, Patient Profiles, Demographics, Vital Signs, Laboratory Findings, and Study Completion)
• Developed SDTM and ADAM datasets.
• Worked extensively on DEFINE.XML for FDA submission for individual studies as well as integrated studies.
• Reviewed OPEN CDISC validator reports to account for compliance checks on the SDTM and ADAM datasets.
• Extensively generated reports using DATA _NULL_, ProcFORMAT,and Proc REPORTand also fordata cleaning and validation.
• Used Proc IMPORT and Proc EXPORT to import data from external sources to SAS and to export SAS file to an external source.
• Worked on basic statistical procedures like Proc UNIVARIATE, Proc ANOVA, Proc REG.
• Generated output files in LST, HTML, RTF & PDF formats using SAS ODS.
• Supported Statisticians to make various characteristic graphs.
• Worked extensively on SAS functions, arrays, formats, delimiters and labels.
• Used Dynamic Data Exchange (DDE) feature of SAS for importing data from MS Access and Excel.
• Developed efficient and readily modifiable SAS code using SAS/BASE and SAS/MACRO Facility.
• Modified existing SAS programs using SAS macro variables to improve the ease, speed and consistency of the results.
• Assisted fellow programmers in validation and edit checks.
• Reviewed study Protocol, AnnotatedCase Report Form (ACRF), and performed validation of clinical trial data to identify illogical data entries.
• Have worked closely with the clinical trial data and generating Integrated Summaries Efficacy (ISE) and Integrated Summaries of Safety (ISS) table, listing, graphs.
• Experienced using industry standards for database design as defined by Clinical Data Interchange Standards Consortium CDISC mapping.
• Involved in creating transport files for electronic submissions to the FDA.
• Performed Quality Assurance Procedure as per user's guidelines and requests.
• Created SAS views from oracle database upon statistician's request.

Environment:SAS/BASE, SAS/GRAPH, SAS/STAT, SAS/MACROS, SAS/ACCESS, SAS/ODS, Oracle, Windows XP, Excel, SQL, SAS/ETL,PL-SQL

Industry:Confidential, Dallas, TX Nov 2010 - Oct 2011
Role:SAS Programmer

Access Pharmaceuticals is a polymer-based drug delivery company with 2 approved products & 2 products in Phase III and Phase IV clinical trials. One of which was for cancer studies. The area of the study was the application of polymeric base drugs to act on the target sites of the tumor. Other areas of study at Access Pharmaceuticals are infectious diseases, inflammation, dermatology and mucosal diseases.

Responsibilities:

• Worked closely in various teams with medical writers, data-managers, clinical monitors and fellow programmers.
• Generated programs in MACROS to generate graphs, listings, quality tables for clinical study reports and regulatory submissions.
• Assisted in providing technical resources of SAS upgrades and licenses.
• Extensive experience in using various SAS BASE procedures such as PROC (IMPORT, EXPORT, PRINT, TABULATE, REPORT, SQL, MEANS.
• Reviewed and provided input on the design of CRF's, databases, SAPs and tables, SDTM, ODM, and ADAM.
• Assisted seniors and follow programmers in validation, edit checks and ad-hoc analyses.
• Sound knowledge of using BASE SAS functions like (ROUND, SCAN, TRIM, LENGTH, PUT, INPUT, DATE, MAX, MIN, MEAN, and STD)
• Created SAS views from oracle database upon statistician's request.

Environment:SAS/BASE, SAS/GRAPH, SAS/STAT, SAS/MACROS, SAS/ACCESS, SAS/AF, ,SQL Server, SAS/REPORT, Windows XP,PL-SQL

Industry:Confidential, Woodland Hills, CAJun 2009 - Oct 2010
Role:SAS Programmer/Analyst

Confidential, is a leading applied health services research company that specializes in transforming healthcare data into meaningful, actionable information. The project involved a detailed study on quality indicators and life sciences research. The objective was to find the impact of the study drug and costs related to treating complications. Also find the quality and efficiency score for providers who treat the patients. Was also involved in phase III study of the therapeutic drug and worked with safety and efficacy reports.

Responsibilities:

• Used Base SAS to perform sorting, indexing, merging of datasets and generated reports
• Extensively used BASE SAS functions like ROUND, SCAN, INDEX, SUBSTR, TRIM, LENGTH, PUT, INPUT, DATE, MAX, MIN, MEAN,.
• Reviewed and provided input on the design of CRF's, databases, SAPs and tables
• Have worked closely with the clinical trial data and generating Integrated Summaries Efficacy (ISE) and Integrated Summaries of Safety (ISS) table, listing, graphs.
• Generating standards for database design as defined by Clinical Data Interchange Standards Consortium CDISC mapping.
• Produced derived data sets, tables, listings and figures for analyses.
• Used Data _Null_, Univariate, Summary, Means, and Freq extensively.
• Developed routine SAS Macros to create tables, graphs and listings for inclusion in clinical study reports and regulatory submissions and maintained existing ones

Environment: SAS/BASE, SAS/GRAPH, SAS/STAT, SAS/MACROS, SQL, Windows XP, PL-SQl

Industry:Confidential, Chadds Ford, PA Mar 2007 - Apr 2009
Role:SAS Programmer

Confidential, are engaged in the research, development, sale and marketing of branded and prescription pharmaceuticals used primarily to treat and manage pain. Extensively worked with statisticians to generate listings, summary reports and tables.Designed tables and graphs for clinical study reports.

Responsibilities:

• Generated statistical analysis files, summary tables, categorical tables, listings and graphs for various Phases of clinical trial studies using various SAS modules.
• Worked on writing, edit checks, validating and debugging code in SAS/BASE and SAS/MACROS.
• Used various procedures such as Proc GPLOT, Proc GCHART, Proc UNIVARIATE, Proc FREQ etc., extensively for presenting the data for analysis.
• Performed various ad-hoc analyses as per user's guidelines and requests.
• Generated summary reports for ISS and ISE analyses of clinical study for FDA regulatory submissions and publications.
• Worked as a part of team consisting of statisticians, medical writers and programmers.
• Conducted statistical analysis for both Continuous and Categorical data, using statistical procedures like Proc REG, Proc GLM etc.
• 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_ step and other statistical procedures.

Confidential, is capable of handling all types of phase I study, from technically complex trials to the more routine bioavailability/bioequivalence study. Its clinical facilities have invasive and non-invasive monitoring capabilities and the potential to record and store data electronically.

Responsibilities:

• Generated Reports on A E (Adverse Events) and SAE (Serious Adverse Events) as a part of clinical study report
• Created the datasets and developed reports as per the statistician requirements
• Created base programs to set up data. Performed data conversions, validation and corrections
• Produced tables, listings and graphs for report submission
• Drew flowcharts indicating input datasets, sorting and merging techniques and writing SAS code accordingly
• Wrote SAS Macros within the program and also used Company Macros
• Done validation of listings and reports to check whether the data is consistent and valid

Environment:SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/MACROS, MS-Excel, Windows NT, SAS,/SQL,SAS/ODS