SUMMARY

• 7+ years of professional in SAS Programming and Statistical Analysis for Clinical Trials in the Pharmaceutical and Biotechnology industries.
• Strong knowledge in all phases of clinical trials from Phase I to IV and FDA procedures: FDA 21 CFR part 11 and also their designs including open - labeled, single blinded, double blinded, randomized, parallel, crossover and sequential studies.
• Extensive experience in SAS products including SAS/BASE, SAS/MACRO, SAS/STAT, SAS/ACCESS, SAS/ODS, SAS/GRAPH, SAS/SQL, SAS/CONNECT and SAS Enterprise Guide.
• Experience with importing various External Data Files into SAS Dataset / SAS Library by using SAS/ACCESS, SAS/INFILE, SAS/IMPORT, SAS/SQL.
• Excellent experience in developing, designing and debugging SAS Programs and SAS/MACRO to access, extract, modify, merge, and analyze data, and also output Statistical analysis files, Tables, Listings, Figures.
• Highly proficient in statistical analysis using PROC FREQ, PROC MEANS and PROC UNIVARIATE.
• Excellent working experience in manipulating datasets: Cleansing, Merging, Combining, Subsetting by using SAS data step and procedures like PROC SORT, PROC TRANSPOSE, PROC APPEND, PROC DATASETS and PROC SQL.
• Expertise in producing customized Tables, Listings and Figures (TLFs) by using PROC REPORT, PROC TABULATE, DATA NULL .
• Excellent work knowledge of SAS/ODS to export SAS results into different formats including RTF, HTML, PDF, XML, etc.
• Worked extensively on various SDTM domains such as AE, CM, LB, DM, SE, EG, EX, IE and their SUPPQUAL datasets.
• Experience in implementing CDISC SDTM (3.1.1/3.1.2 ) for interventions, events and findings domain models and ADaM (2.0, 2.1) standards, Define .xml and CRTs.
• Fluent with GCP and GPP used for NDA and regulatory submission.
• Strong skills in Oracle Database, SAS, SQL, PowerPoint, MS Excel, MS Word, and MS Access.
• Fair knowledge in producing TLF’s using PROC GPLOT and PROC GCHART and also CRF, SAP, Protocol and SOP.
• Worked extensively on Windows and UNIX environments
• Good Knowledge on Pharmacokinetic and Pharmacodynamic properties of the drug.
• Good team player with conflict resolution skills.

TECHNICAL SKILLS

Statistical Software: SAS 8.0/8.2/9.0/9.1/9.2 , SAS/BASE, SAS/ACCESS, SAS/MACRO, SAS/ODS, SAS/SQL, SAS/STAT, SAS/REPORT and SAS/GRAPH.

Programming Languages: SAS, SQL, HTML, C, C++

Database: Oracle, DB2, Teradata.

PROFESSIONAL EXPERIENCE

Confidential, NC

Senior Clinical SAS Programmer

Responsibilities:

• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS/Base, SAS/Macro and SAS/Graph, SAS/SQL.
• Extensively used PROC UNIVARIATE, PROC MEANS, PROC FREQ, PROC SORT, PROC FORMAT, PROC CONTENTS, PROC REPORT, PROC SUMMARY, PROC SQL, PROC GPLOT and PROC GCHART procedures.
• Produced quality customized reports by using TABULATE, REPORT, and SUMMARY and also provided descriptive statistics using MEANS, FREQ, and UNIVARIATE.
• Reviewed Clinical Study Protocol, Clinical Data Management Plan, Data Analysis Plan documents and also implemented CDISC SDTM.
• Developed, modified, validated and implemented SAS programming work based on SAP. Devised and maintained programs that create pooled databases from clinical studies.
• Created and tested programs that generate summary tables, data listing, and figures (TLFs) for inclusion in clinical study report (CSR) and ad-hoc reports.
• Developed and maintained general-purpose and ad hoc SAS programs/Macros for the validation, extraction, presentation, manipulation, analysis, and reporting.
• Contributed to Integrated Summary of Safety Analysis Datasets for clinical Studies and created SAS customized reports using DATA NULL technique for reporting.
• Formatted HTML and RTF reports, using SAS - output delivery system ODS and collaborated with project biostatistician to analyze the statistical models.
• Reviewed of Clinical data for FDA Submissions and contributed to Clinical Study Report. Ensured analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting.

Environment: SAS 9.1, SAS/Base, SAS/Macros, SAS/SQL, Windows XP.

Confidential, Gaithersburg, MD

Clinical SAS Programmer

Responsibilities:

• Responsible for manipulating and analyzing data, generating statistical analysis using SAS; developing SAS MACRO to generate tables, listings, graphs and producing output files for use in reports or for use by statistician and research staff.
• Created SAS data sets by extracting data from Oracle tables using SAS/SQL and SAS/ACCESS and prepared them for statistical analysis.
• Performed Data cleaning and validation using SAS data step and SAS procedures.
• Produced summary statistics using Proc Means, Proc Summary, Proc Freq, Proc Univariate.
• Performed statistical analysis using SAS/STAT procedures like Proc ANOVA and analyzed adverse event (AE) data using Proc Freq and also provided output for the Clinical Study Report (CSR).
• Created customized listing, tables, and graphs (TLG) according to Statistical Analysis Plan (SAP) using Proc Report and SAS/ODS.
• Developed SAS MACRO to generate graphs and reports based on combined datasets, performed statistical analyses with SAS/ODS.
• Validate the derivative variables and data sets with other programmers output using Proc Compare.
• Review CRF (case report form) design and clinical data management plan.
• Cross-validated SAS programs authored by other SAS programmers as a part of QA (quality assurance).
• Worked closely with Data Management to support data integrity checks and adherence to data definition standards.
• Collaborated with statisticians and medical researchers in preparing formal reports and regulatory submission.

Environment: SAS 9.1, SAS/Base, SAS/Macros, SAS/SQL, SAS/STAT, Windows XP and MS Access

Confidential, Parsippany, NJ

Clinical SAS Analyst

Responsibilities:

• Wrote codes using SAS/BASE and SAS/MACROS to extract clean and validate data from Excel file, Access Database, and Microsoft SQL server.
• Performed Data analysis, Statistical analysis, generated reports, listings and graphs using SAS/BASE, SAS/MACRO and SAS/GRAPH, SAS/SQL, SAS/ACCESS. Assisted the Clinical Data Management group to design or review database structures.
• Integrated data from different studies and contributed to Integrated Summary of Safety (ISS) for clinical Studies. Conducted Statistical Analysis for individual and integrated studies.
• Developed routine SAS/MACROS to create Tales, Listings and Figures (TLFs).
• Created SAS customized reports using DATA NULL technique for reporting.
• Produced quality customized reports by using PROC TABULATE, REPORT, PROC SUMMARY and also provided descriptive statistics using PROC MEANS, PROC FREQ, and PROC UNIVARIATE.
• Built Macros and applied existing Macros to produce customized graphs. Dealt with several statistical procedures like PROC GPLOT which were used to build graphs for inclusion of reports and FDA submissions.
• QC of the Derived data sets and the statistical results created by others.
• Formatted HTML and RTF reports, using SAS - output delivery system ODS.
• Contributed to CSR and documents submit to FDA.

Environment: SAS/Base, SAS/MACROS, SAS/SQL, SAS 8.2, MS Excel, and UNIX

Confidential

Clinical SAS Programmer

Responsibilities:

• Worked with clinical research staff to provide SAS programming support to clinical study group for Clinical Trial projects.
• Assisted with analysis planning including review of table and listing mockups and analysis dataset requirements.
• Validated programming output and mockups in SAP using PROC COMPARE.
• Used DATA STEP to derive analysis dataset from raw dataset using define feature in SAP and Clinical Report Forms.
• Used various procedures like PROC REPORT, PROC FREQ, PROC TABULATE, PROC MEANS AND PROC SUMMARY to generate various data tables, patient data listings and reports according Statistical analysis plan.
• Contributed to Integrated Summary of Safety Analysis.
• Created tables, graphs, and listings for inclusion in clinical study reports, and regulatory submissions and maintained existing ones by using SAS MACROS.
• Ensured analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting.
• Prepared detailed analysis plan from study protocol with biostatisticians.
• Written customized safety and efficacy reports directing SAS output to RTF and HTML files using Output delivery System (ODS) facility.

Environment: SAS/Base, SAS/MACROS, SAS/SQL, SAS 8.2, MS Excel, and UNIX.

Confidential

SAS Programmer

Responsibilities:

• Cleaned datasets and loaded clinical data into databases for further reporting based on report specification.
• Imported datasets from different sources like a spreadsheet of Excel, part of a spreadsheet of Excel, data file with delimiters, and so on.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS Tools SAS/Base, SAS/Macro and SAS/Graph, SAS/SQL, SAS/Access.
• Wrote SAS code for data management and reporting, and performed validation, including testing SAS code.
• Techniques used in SAS include file merging, frequency and Report, Transpose, Summary, and Means Procedures, writing to external files.
• Developed routine SAS macros to create tables, graphs and listings.
• Produced quality customized reports by using PROC TABULATE, REPORT, and SUMMARY and also provided descriptive statistics using PROC MEANS, PROC FREQ, and PROC UNIVARIATE.
• Formatted HTML and RTF reports, using SAS output delivery system ODS.
• Performed in-depth data analysis and model testing.
• Created SAS customized reports using DATA NULL technique.