SUMMARY:-

• Over 7 years of experience in SAS programming and clinical trials.
• Excellent command in various SAS procedures, like Proc PRINT, Proc REPORT, Proc SUMMARY, Proc FREQ, Proc TABULATE, Proc MEANS, Proc UNIVARIATE, Proc TRANSPOSE, Proc SQL, Proc SORT, Proc CONTENTS, Proc COMPARE, Proc GPLOT, Proc IMPORT, Proc EXPORT, Proc GLM, Proc REG, Proc TTEST, Data NULL etc.
• Proficiency in performing Data Cleaning and Validation analysis using SAS/BASE, SAS/MACRO.
• Excellent knowledge of FDA and ICH GCP requirements.
• Exposure to FDA 21CFR Part 11 guidelines.
• Designed and developed SAS reports using SAS in Html, PDF and RTF formats.
• Thorough knowledge of Clinical Trials and Involved in all Phases of Clinical trials including Data manipulation and Statistical Analysis.
• Familiar with SAS Access, SAS/STAT, SAS/Connect.
• Extensive experience in preparation of reports, tables, listings and graphs.
• Extensively involved for generating Efficacy and Safety Reports in accordance with the GCP guidelines.
• Involved in the creation of SAS data sets, reports, listings, graphs and tables according to the Standard Operating Procedures SOPS .
• Excellent communication and interpersonal skills which helps contribute to timely completion of project deliverables well ahead of schedule.

TECHNICAL EXPERTISE:-

• Programming Languages: Statistical Programming using SAS, SAS Macro, Proc SQL, SAS ODS, Excel, C, PL/SQL.
• Operating Systems: MS Windows XP/2000/NT/98.
• Databases: DB2, MS Access.

PROFESSIONAL EXPERIENCE:-

Confidential

Clinical SAS Programmer

Responsibilities:-

• Conduct analyses and generate tables, listings, and graphs using SAS.
• Responsible for the proper coding, documentation and validation of SAS programs/ macros/ procedures to produce the standardized data display.
• Perform verification of SAS-generated output tables, listings and graphs via independent programming.
• Establish and maintain libraries of fully documented and validated applications programs / macros / procedures which are used and recycled.
• Proficient in statistical techniques - Descriptive statistics measures of central tendency and variability, cross-tabs, and frequencies, inferential statistics e.g., t-test, ANOVA, multivariate analyses, correlations, Chi-square, linear and non-linear regression modeling, and time-series analysis .
• SAS Procedures: ANOVA, CHART, CIMPORT, CONTENTS, COPY, CORR, DATASETS, FORMAT, FREQ, GLM, GENMOD, IMPORT, LIFETEST, LOGISTIC, MEANS, MIXED, PHREG, PRINT, PRINTTO, REG, REPORT, SQL, SORT, SUMMARY, TABLUATE, TEMPLATE, TTEST, and UNIVARIATE.
• Clinical Data Management using DATALABS for Electronic data Capture EDC .
• Assist in preparing clean databases and resolving verification discrepancies.
• Review CRF's and data listings to ensure that all captured data follow the rules outlined by the protocol and data management plan.
• Interact and collaborate with project team members to support the set-up, maintenance, and closure of data management aspects of project to ensure consistent, cohesive data handling and quality.
• Evaluation and analysis of CMS Medicare data, Generate reports to address access/ utilization of VA/Medicare services.

Confidential

Biostat Programmer

Involved in SAS programming with Clinical Research data for Phase III Clinical Trials Oncology and Neurology. Developed dynamic SAS programs using SAS Tools like SAS/Base, SAS/Macros Programming for NDA submission item 11 in accordance to report specifications.

Responsibilities:-

• Created and maintained analysis datasets from raw datasets.
• Programmed edit checks to satisfy data collection, storage, and analysis for clinical studies.
• Created and validated programs for Phase III clinical trial initiatives, responsible for production of analysis datasets, data listings and summary tables.
• Performed data validation and checking for program errors using SAS.
• Formatted HTML, PDF and RTF reports, using SAS - Output Delivery System.
• Created Ad-hoc reports for analysis datasets by using Proc Reports and Proc Tabulate.
• Developed listings, tables and Graphs for Efficacy and Safety for the clinical studies.
• Created standard programs including SAS macros.
• Extensive use of the TRANSPOSE, UNIVARIATE, SUMMARY, MEANS, FREQ, TABULATE, CONTENTS, SORT, PRINT, GLM, SQL, GPLOT and GCHART procedures.
• Produced statistical tables, listings and analysis. Analyzed data using SAS/Stat procedures.
• Involved in the development of clinical trial data tables demographic data tables, discrepancy data tables, Adverse Events AE tables, Serious Adverse Events SAE tables and Laboratory data tables.

Confidential

Clinical SAS Programmer

MGI Pharma, Inc. is an oncology-focused biopharmaceutical company that acquires, develops and commercializes proprietary products that address the unmet needs of cancer patients. This project involves the creation of SAS data sets using the raw clinical data for analyzing the safety and efficacy reports. The project was based on the oncology studies of prostate and colorectal cancers.

Responsibilities:-

• Responsible for providing SAS programming and analysis support for Phase II clinical study.
• Generate tables, listings and graphs, including Patient Demography and Characteristics, Adverse Events, Laboratory etc.
• Reviewed data from clinical trials and developed plans to presenting results to FDA.
• Created SAS datasets in local SAS directory.
• Created SAS views from database tables using SAS/ACCESS and writing SAS programs using BASE SAS and SAS MACROS to create SAS reports.
• Worked with Statisticians in generating SAS analysis datasets, production of data listings, summary tables, and statistical analysis.
• Extensively used PROC Report and PROC Tabulate to create reports.