• Certified SAS Programmer with over five years of experience in analysis, design, development, testing and implementation of Clinical Trial projects.
• Expertise in preparation of reports, tables, listings and graphs, sorting and merging of data validations.
• Extensively involved in Clinical Data Analysis and preparation of SAS Datasets, according to the Standard Operating Procedures (SOPs) and departmental guidelines.
• Thorough knowledge in Clinical Data Analysis using Oracle Clinical, Clintrial and SAS.
• Performed data conversions, and developed SAS programs for Data Cleaning.
• Involved in Design, Development and Implementation of various statistical analysis projects for Pharmaceutical companies.
• Extensive experience in using DATA_NULL_data step for producing customized reports.
• Knowledge in preparing Integrated Summaries of Efficacy (ISE) and Safety (ISS) reports.
• Worked with senior Bio-statisticians and clinical data management team.
• Through knowledge of CDISC STDM and ADAM Standardization.
• Excellent experience in storing and managing large data in SAS files, merging SAS data step, Do-Loops, Macros, SAS Formats, and SAS In formats.
• Thorough knowledge and experience in Regression Analysis, Linear Models, Sampling Theory, Analysis of variance.
• Experience in data transformations & edit check and commanding experience in analyzing Case Report Form (CRF) data.

TECHNICAL EXPERTISE

SAS Procedures/Tools: SAS/BASE, SAS/MACRO, SAS/GRAPH, SAS/ODS, SAS/STAT, SAS/GRAPH, SQL, MEANS, REPORT, PRINT, UNIVARIATE, REG, GLM, CORR, FREQ, SUMMARY, IMPORT, EXPORT, SORT, TABULATE, FORMAT, TRANSPOSE, CONTENTS, ANOVA ,Oracle clinical,Clintrial Languages : C, C++, JAVA, SQL, HTML, DHTML Operating Systems : Windows95/2000, Windows XP, MS DOS, and UNIX Databases : Oracle 8/9i, MS-Access 98/2000/2003, SQL Server Packages : MS Office 97/2000/2003/2007

Statistical SAS /Clinical Programmer Confidential, South San Francisco, CA March 2010 -June 2010

Responsibilities:

• Providing SAS programming and Analysis support for early development group, phase 1 oncology clinical drug trial.
• Responsible for developing new SAS programs and modifying existing programs and creating new listings and graphs.
• Participated with early development of the cancer drug in producing the tables and graphs.
• Generated tables and listing for demographic and adverse events for all grades.
• Generated death and reason for discontinuation tables and helped in the analysis of the output of the drug with the help of the bio-staticians.
• Participated in the PPd meeting and early development of the drug.
• Reviewing of the protocol, Sop and CRF under the guidance of the bio-statician and science group.
• QC program generated by the other developer for safety analysis.
• Imported and exported data from other data sources such as Excel.
• Involved in Statistical aspects of Clinical Trials, experimental design, data analysis, summarizing and reporting.
• Developed reports using PROC REPORT, PROC TABULATE and DATA _NULL_.
• Wrote statistical sections of Clinical Study Reports and assisted in preparing integrated Clinical / Statistical reports.

Statistical SAS/Clinical Programmer Confidential, Hopewell, NJ Sept'07 - Jan'09

Responsibilities:

• Responsible for providing SAS programming and analysis support for Phase I and Phase 2 oncology clinical drug trial.
• Developed SAS programs to validate programs written by other SAS programmers.
• Being part of ISS team worked closely with the rest of the team in analyzing multiphase trial data and generated integrated summary of safety data sets, per SAP.
• Created validation and derivation procedures as needed in CDMS.
• Wrote programs to generate data discrepancy reports using edit check specifications provided by study data analyst.
• Generating the demographic tables, adverse events and serious adverse events reports.
• Used SAS/ACCESS to extract data from oracle and other relational database for analysis. Creating datasets from flat files excel worksheet.
• Prepared data for FDA submission as per CDISC submission standards and guidelines. I was involved in creating annotated case report form using CDISC-SDTM mapping.
• Worked extensively in FDA submission, with good knowledge of 21 CFR parts 11.
• Moved data sets across platforms (from PC & Mainframe to UNIX & Vice Versa).
• Involved in validating and QC of the efficacy and safety tables.
• Review and integration of data obtained from electronic data capture and extracted data from oracle clinical.
• Effectively involved in the management of large data set and programming the data set.
• Modified existing SAS programs and created new programs for better performance and ease of use. And programs have been standardized using SAS macros.

Environment: SAS 8.2, SAS/Base, SAS/Macro, SAS/SQL, UNIX, Shell Scripting, SQL, PL/SQL, Oracle Clinical, HP-UNIX, Windows 2000, and MS Excel

Statistical SAS/Clinical Programmer Confidential, Deerfield, IL Oct' 06 - Sept' 07

Responsibilities:

• Participated in writing of clinical trial reports (phase I-II), analyzing, and presenting trial results for epidemiology of diabetes clinical trial.
• Developed efficacy analysis/ derived datasets implementing LOCF, visit windowing based on duration of treatment and other data transformations as specified by the Statistical Analysis Plan (SAP)
• Review/approve programming plan specifications, SOPs and other documents directly impacting the deliverables
• Created Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) databases.
• Responsible for developing programs with SQL, for extracting data from Oracle tables.
• Creating the Ad hoc reports using the SAS procedures and PROC TEMPLATE to generate different output formats like HTML, PDF.
• Worked with Efficacy questionnaires such as Patient Perception, Health related quality of life questionnaire and other measurements.
• Was involved in creating CRT's for an NDA electronic submission to the FDA
• Imported and exported data from other data sources such as Excel.
• Also involved in validation of my fellow programmer code. I have developed Edit check programs to clean invalid data from the database.
• Knowledge of regulation such as CDISC STDM and ICH guidelines, also ADAM implementation of standardization for the analysis dataset.

Environment: SAS/Base 8.2, SAS/Macros, SAS/Stat, SAS/Graph, SAS/ODS, SAS/SQL, SAS/Connect, SAS/Access, Oracle 8i, MS-Excel, UNIX.

Confidential SAS Programmer Analyst - Clinical Trials Apr' 04 - Sept' 05

Responsibilities:

• Worked collaboratively with statistical programmers, statisticians, and data managers on a large, multi-center, phase II clinical trial.
• Involved in quality assurance of data, automated processes, programmed data manipulation and graphics, validated programming and presented results.
• Prepare clinical data listings and summaries for statistical analysis and analyzed clinical data using SAS system.
• Developed routine SAS macros to create tables, graphs and listings for inclusion in Clinical study reports and regulatory submissions and maintained existing ones.
• Used SAS for pre-processing data, SQL queries, and data analysis, generating reports, graphics and statistical analysis.
• SAS/STAT was also used to perform analysis of variance for balanced or unbalanced designs, multivariate analysis of variance and repeated measurements analysis of variance.
• Supported the research staff for technical and programming help. Worked with Bio-statistician to analyze the results obtained from various statistical procedures like PROC ANOVA, GLM, and T test.
• Produced quality customized reports by using PROC TABULATE, REPORT, and SUMMARY and also provided descriptive statistics using PROC Means, Frequency, and Univariate.
• Integrated data to process clinical trail studies from multiple sites for statistical evaluation.

Environment: SAS 6/8, SAS/BASE, SAS/MACROS, SAS/GRAPH, SAS/SQL, PL/SQL, Oracle 8, ANOVA, Windows NT and UNIX.

Statistical SAS/Clinical Programmer Confidential Feb' 03 - Mar' 04 Responsibilities:

• Project focused on the development of innovative products for the treatment of cancer and study of epidemiology of chronic illness (Phase II & III).
• Extracted, analyzed data and directed to different output files such as Excel spreadsheets and DBF files.
• Converted MS Word documents, MS-Excel, Oracle tables into data sets.
• Creation / implementation / integration / validation of data quality checks for clinical trials data quality system.
• Successfully created reports in HTML, PDF and RTF format using SAS ODS.
• Developed reports using PROC REPORT, PROC TABULATE and DATA _NULL_.
• Wrote statistical sections of Clinical Study Reports and assisted in preparing integrated Clinical / Statistical reports.

Environment: SAS 6/8, SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/SQL, Excel 2000, Windows 95/XP

Education

• Master in Public health (M.P.H)
• Bachelors of Dental surgery (B.D.S)

Research experience

• Study was assess the efficacy, safety and preventive of therapeutic intervention on case control epidemiology oral diseases, to improve the prevention and treatment of infectious diseases,
• Clinical study on the epidemiology of tobacco chewing, the study was a cohort study design and was to prevent oral cancer I large number tobacco chewing elderly population.
• Clinical study involving epidemiology study of Dental caries prevalence and treatment levels of nursing bottle caries in Pedodontic department patients, of J.S.S dental college and Hospitals.