Summary:

• Certified SAS programmer with over six years of experience in SAS Programming and Statistical Analysis with strong emphasis in Clinical research and analysis, design of experiments, development, testing and implementation of various projects for Pharmaceutical, and Biotechnology Industries.
• Experience in all statistical aspects of study trials: experimental design, selection of appropriate statistical methodology, sample size estimation, protocol review, data analysis and summarization and reporting.
• Extensive hands on experience in programming using BASE SAS, SAS/STAT, SAS/ACCESS, SAS/GRAPH, SAS/SQL, SQL in Windows.
• Advanced skills on data cleaning and manipulation using procedures such as PROC SUMMARY, PROC SORT, PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC FORMAT, PROC TRANSPOSE, PROC PRINT, PROC REPORT, PROC TABULATE, PROC COMPARE, PROC CDISC and many SAS data steps such as ARRAY, MERGE, SET, etc.
• Extensive knowledge in storing, reporting and managing data, developing SAS Procedures, Macros, and application for data cleaning, reporting and documentation.
• Experienced in editing and validating programs using SAS macros to generate listings and tables, data step manipulations for data quality assurance/ validation of table, listing and summaries.
• Used SAS extensively to analyze clinical data from CRF’s, creating SAS data sets for the purpose of analysis and report writing for clinical trials (Phase I through Phases III), generating efficacy and safety reports, creating datasets and generating reports using PROC Tabulate, PROC Report, Data _Null_, SAS arrays, PROC SQL and Macros.
• Experienced in modifying existing SAS programs and creating new programs using SAS macro variables.
• Experienced in creating reports in HTML, RTF format using ODS statements and PROC TEMPLATE for Regulatory submissions.
• Developed AE datasets and tables using MedDRA.
• Good knowledge of 21 CFR part 11, medical and statistical terminology and CDISC guidelines.
• Well versed with CDISC compliant data models & CDISC’s SDTM Implementation guidelines for CSR development.
• Experienced with Clinical Trials data like Demographic data, Discrepancy data, Adverse Events, Serious Adverse Events, Laboratory data, Physical and Vital Signs.
• Experienced in Table Programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS).
• Also experienced in creating and extracting Oracle tables from SAS by using SAS/SQL Pass-Through-facility.
• Experienced in Statistical aspects of Clinical Trials, experimental design, data analysis, summarizing and reporting.
• Good knowledge of basic statistical concepts, data structure and data management principles and ability to comprehend clinical study documentation (protocols, CRF\'s, etc).
• Strong skills in SAS data step programming, including merging and reading external data files, SAS descriptive procedures, such as FREQ, UNIVARIATE, MEANS, and SUMMARY.
• Extensive knowledge and experience of Microsoft Office tools like MS Access, MS word, MS PowerPoint, MS Excel.
• Excellent time management capabilities, including the ability to prioritize diverse tasks within the overall context of a fast-moving project.
• Excellent written and verbal communication skills along with the ability to present clear and concise data from experimental results.
• The desire and ability to be a team player, along with the skills necessary to be a key project team member and to coordinate effectively with different project teams.
• Demonstrated ability to self-motivate, function independently and multi-task with minimal direction.

TECHNICAL SKILLS:

• Statistical Software: SAS (8.x, 9.x), MS-Excel, SPSS, MINITAB.
• SAS Product: SAS/Base, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/SQL, SAS Enterprise Guide.
• Operating Systems: UNIX, Windows (95, 98, 2000, NT, XP).
• Database: Oracle, SQL, MS Access, MySQL, DB2.
• Web Technologies: HTML, XML, Front Page, Macromedia Dreamweaver, Adobe Photoshop.
• Application Software: MS Office (Word, Excel, Power Point, Access).

PROFESSIONAL EXPERIENCE:

Confidential, ( Feb 07- present )
SAS Programmer

Confidential has leading products in the areas of primary health care, neurology, gastro intestinal, dermatology, vaccines and infectious disease, immunology and oncology. Working as SAS Programmer using clinical data for neuromuscular clinical trials. Involved in Phase II and Phase III of clinical trials and responsible for doing EDA, edit checks and cleaning the lab data for reporting and submitting reports.

Responsibilities:

• Extraction of raw data from Oracle data base and converted Oracle data tables into SAS data files using libname and SAS/ SQL Pass through Facility.
• Creating of VAD (value added data) and CDISC-SDTM compliant datasets from raw data for analysis purposes.
• Reviewed study Protocol, Case Report Forms (CRFs) and performed validation of clinical trial data to identify illogical data entries.
• Extensively used existing macros and created new macros for reporting and analysis.
• Produced customized reports by using PROC REPORT, PROC SUMMARY, PROC TRANSPOSE, Data _NULL_ and PROC TABULATE and also provided descriptive statistics using PROC MEANS, PROC FREQ, and PROC UNIVARIATE.
• Used MedDRA for summary of events to include adverse event body system and preferred terms.
• Organized and streamlined data records into more user-friendly formats.
• Used SAS/Base to perform sorting, indexing, merging on the clinical data and generated reports.
• Performed validation on the Datasets for CDISC SDTM compliance of before submission.
• Created electronic data sets (i.e., SAS transport files) for E-submission.
• Worked with presentation and reporting procedures like REPORT, PRINT.
• Used ODS to produce HTML, PDF and RTF format files.
• Meeting with SAS Developer/Bio Statistician/Clinical Data Coordinator/Clinical Data Manager/Clinical Research Coordinator for clinical trial protocol reviewing, Clinical Data Management Plan reviewing, and Clinical Study Report submitting.
• Balance concurrent tasks/priorities within defined timelines.
• Worked under the direction and supervision of Manager, Clinical Data Management.

Environment: SAS 9, SAS/Base, SAS/SQL, SAS/Graph, SAS/Access, SAS/Stat, Oracle, SQL, Windows

Confidential (Dec 04 to Feb 07)
SAS Programmer

Responsibilities:

Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros, SAS/ Access, My SQL, SQL, MS – Access and MS-Excel

Confidential (Feb 03 - Nov 04)
SAS Programmer

Confidential is largest pharmaceutical company, is an integrated, research based, international pharmaceutical company, producing a wide range of quality, affordable generic medicines. The information, collected as CRF (Case Report Form or Clinical Report Form) was entered as data entries and sent to us as raw clinical data. The data collected was in different forms like Lab data, Drug dose data, Visit/contact, Investigator, Questionnaire, demographics etc. The project involved statistical analysis of Phase II Clinical Trials data extraction, analyzing and reporting.

Responsibilities:

• Work with senior Bio-statisticians and clinical data managers to provide SAS programming in analyzing the data, generate reports, tables, listings and graphs.
• Use PROC Tabulate and PROC Report to standardize the reporting programs into macros.
• Use SAS/STAT software for Statistical Analysis, procedures and reports
• Create and maintain SAS Datasets that are extracted from an Oracle Database using SAS/ACCESS.
• Develop SAS code to clean the invalid data from the database.
• Developed patient profiles with safety and efficacy information for clinicians review
• Developed efficacy graphs for each patient for quick review by clinicians
• Used PROC SQL, DATA_NULL and PROC REPORT judiciously for development and customization of reports and listings.
• Developed and managed MACROS that eliminate redundant coding
• Successfully designed and implemented statistical reporting processes for clinical data collection and data analysis. Analyzed Phase I, II and III of Clinical Trials.
• Proficient in drawing flowcharts indicating the input data sets, sorting and merging techniques to get the required report.

Environment: SAS/BASE, SAS/ACCESS, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/SQL, Windows, UNIX, Oracle, SQL.

Confidential ( Dec 1999 – Sept 2002)
Research Fellow

Responsibilities:

Provided SAS programming expertise in the production of datasets, tabulations, graphics, and summaries from microbiological data for decomposition studies. Cleaning, Validation, Analysis, Report and presentation generation. Present results to research team, and write final reports to the funding agency.

• Statistically analyzed and interpreted the project data using SAS and SPSS software. Some of the graphics were done using SigmaPlot and Grapher software.
• Successfully prepared all the project reports including Exploratory Data Analysis and the final statistical interpretation and presentation.
• Wrote code using SAS/Base and SAS/Macros to extract clean and validate data from Excel file, Access Database, and My SQL.
• Performed Data analysis, statistical analysis, generated reports, listings and graphs using SAS/Base, SAS/Macro and SAS/Graph, SAS/SQL, SAS/Access.
• Helped collect the research data in a multidisciplinary scientific project.
• Developed SAS programs to generate randomization lists, statistical reports and graphs.
• Performed extensive sorting, merging, concatenating, and modifying of SAS data sets.
• Recruited and trained the research project staff for collection, entering and archiving the data.
• Worked under projected timelines for the final project reports submitted to the Council of Scientific & Industrial Research, Govt. of India.
• Prepared manuscripts for scientific publication in national & international journals.
• Managed the project database for its long-term use in subsequent years.

Environment/Tools: SAS/BASE, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/ACCESS SPSS, MINITAB, MS Access, MS-Excel, My SQL, SQL, SigmaPlot, Grapher.

EDUCATION & CERTIFICATIONS:

• BS
• MS,
• SAS® Certified Base Programmer for SAS 9.
• SAS® Certified Advanced Programmer for SAS 9.