Professional Summary:

• Base SAS Certified and has 7 years of extensive experience as SAS programmer, SAS Analyst in Clinical/Pharmaceutical, Medical Technology Industries and Banking for data analysis, coding and implementationin Windows and UNIX environments.
• Extensive experience in Statistical Analysis, Reporting and Clinical Data Management involving Analysis, design, development, testing and validating the applications.
• Experience in handling complex processes using SAS/BASE, SAS/MACROS, SAS /SQL, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/ACCESS.
• Proficient in Importing or extracting data using Import techniques to create SAS datasets from various sources like Relational databases by connecting SAS System to database systems, such as Microsoft SQL ,Oracle, Excel, flat files , and Exporting data to generate dynamic reports in HTML, RTF, XML,Excel, and PDF formats by using SAS/ODS .
• Knowledge of collecting client\'s requirements and accessing datasets from the client\'s data warehouse using Base SAS.
• Programming experience with procedures like PROC DATASETS, PROC PRINT, PROC APPEND, PROC GPLOT, PROC GCHART, PROC COMPARE, PROC IMPORT, PROC EXPORT, PROC FORMAT, and PROC COPY.
• Hands on experience in data management like Merging, concatenating, interleaving SAS datasets using MERGE and SET statements in DATA step and using PROC SQL.
• Creating new SAS Programs using SAS MACRO to improve ease and speed of modifications as well as consistency of results.
• Expertise in using SAS report generating procedures like PROC REPORT, PROC SQL, PROC TABULATE, PROC TRANSPOSE, PROC SUMMARY and Optimized performance using Data Validation and Cleaning on Clinical Trial data using statistical procedures like PROC FREQ, PROC ANOVA, PROC MEANS, and PROC UNIVARIATE.
• Proficient in CDISC standards and transforming raw data to create datasets following these standards
• Proficient in performing QC on programs by developing Quality Control (QC) procedures
• Knowledge of using SAS 9.2/Enterprise Guide in Data Analysis, understanding of RDBMS (Oracle 8/8i/9i, 10g), PLSQL, Microsoft Excel, PowerPoint. Programming in C and UNIX.
• Good knowledge of Drug Development Process including all clinical trial phases I-IV.
• Expertise in working with clinical trial data like demographic, AE, SAE, Lab, Vital Signs and CRF/e-CRF, other essential documents in clinical Research.
• Experience in Clinical Data Analysis in accordance with guidelines and providing Clinical Study Reports.
• Possess strong ability to quickly adapt to new applications and platforms. Experience in interacting with clients, multiple user groups and managing development teams.
• Experience in supporting multiple projects under deadlines often with competing priorities and complexities by applying critical thinking, problem solving, and decision making skills to optimize solutions.

Certifications:

• Certified Base SAS programmer for SAS9

Technical Skills:

• SAS TOOLS: SAS9.1.3,SAS9.2,SAS/BASE,SAS/MACROS,SAS/SQL,SAS/STAT,SAS/GRAPH, SAS/ODS, SAS/ACCESS.
• SAS PROCEDURES: CONTENTS, PRINT, SORT, IMPORT, EXPORT, DBLOAD, DATASETS, TRANSPOSE, PRINTTO, FORMAT, SQL,REPORT, TABULATE, MEANS, FREQ, SUMMARY, ANOVA, CHART, PLOT, GPLOT, GCHART
• OPERATING SYSTEMS: UNIX, LINUX, WINDOWS 98/XP/2000/NT
• DATABASES: ORACLE 8/8i/9i, 10g, ORACLE CLINICAL
• LANGUAGES : SAS 9.2, SAS Enterprise Guide, C, PL/SQL, PERL
• OFFICE TOOLS: MS-OFFICE, Word, Excel, PowerPoint, HTML

Professional Experience:

Confidential., NJ Jul'12 - Till date
Clinical trial Programmer

Confidential, one of world's leading Pharmaceutical Company, researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions in varied therapeutic areas. The project was analysis of Phase-III clinical trial data of multiple studies.

Responsibilities:

• Programming according to specifications, creating analysis datasets, listings, tables and figures for phase III clinical trials with high quality and within milestones
• Developing and complying with project/study standards and specifications following internal guidelines.
• Generated Tables, Listing and Graphs according to the Statistical Analysis Plan (SAP).
• Good knowledge about URS (user requirement specifications) and immensely involved in creating IVRS (Y1, Y5 & Y7) datasets.
• Created, validated, documented, and maintained SAS programs to generate analysis datasets, and create safety/efficacy reports including summary tables, listings and graphics for use in regulatory submission.
• Interacted with other line functions, such as Biostatistics,Data Management, to ensure a high level of client satisfaction through successful execution
• Created SDTM annotated CRF documents.
• Generated Macros for tables and listing and used department Macros to produce reports
• Performed quality controls (QC) on SAS programs created by fellow programmers.
• Good Knowledge about CDISC and SDTM standards.
• Using SAS/ Base and SAS/ Macro facility developed efficient, well-documented and modifiable
• SAS code
• Experience in handling multi-tasks in tight timelines

Environment: SAS/GRAPH, SAS/STAT, SAS/BASE, SAS/MACROS, SAS/SQL, UNIX, SAS9.2, SAS9.3.

Confidential , NJ Dec'10 - Jul'12
Clinical Application Programmer/Analyst
Confidential is a leading global medical technology company which focuses on improving drug delivery, advancing research, discovery and production of new drugs and vaccines and serves healthcare institutions, researchers, clinical laboratories, the pharmaceutical industry and the general public. The project was analysis of Phase-III clinical trial data to evaluate whether the investigational 4mm x 32 Gauge (G) pen needle manufactured by Confidential provides equivalent glucose control (as measured by fructosamine levels) as the currently marketed Confidential 5mm x 31 G and Confidential 8mm x 31 G pen needles (PN) in diabetic subjects with varying insulin dosage regimens.
Responsibilities:

• Performed data analysis on data which was received every three weeks from client side and according to the requirements generated the reports and participated in other clinical programming and data management activities
• Collected requirements from statisticians, prepared requirements document, follow up and developed new macros as per statistician's request.
• Attended project team meetings, interacted with Bio-Statisticians, Data Managers, and Clinical Research Managers.
• Involved in generating ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) for ISR (Integrated summary report) to compare and to differentiate all other study results and to get conclusion after reviewing the patient benefit/risk profile of drug.
• Involved in Extensive coding in base SAS (including Creating Derived Datasets, Tables to produce desired output format, analysis Datasets, Tables, Listing and Graphs.
• Importing data from different file formats and creating datasets to get desired output using Import procedure.
• Extracted data from Oracle Clinical database using SQL Pass through facility.
• Sorting the data and deleting duplicates by using procedures like PROC SORT in order to produce quality results
• Creating SAS code to clean the invalid data using SAS Macros and SQL procedure.
• Sorting, printing and summarizing the datasets to modify and combining SAS datasets using sort procedure, set and merge concepts.
• Developed SAS programs to format the data for understanding and used various validation techniques such as proc summary, proc means, and other data step techniques.
• Developed SAS Customized Reports using REPORT, TABULATE procedures and DATA _NULL_.
• Developed daily input report, monthly reports using PROC SUMMARY, PROC TABULATE and PROC ANOVA and generated tables and listings using various procedures like PROC MEANS, PROC FREQ, PROC TRANSPOSE, PROC REPORT, PROC UNIVARIATE, and generated graphs using PROC GCHART and PROC GPLOT.
• Generated the reports in desired output format (HTML, PDF and RTF format files)for decision making using SAS ODS (OUTPUT DELIVERY SYSTEM)
• Listings and Reports were created by patient, Treatment group using Proc Report

Environment: Oracle Clinical 4.x, SAS 9X, SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/MACRO, SAS/ACCESS, SAS/ODS, UNIX, MS Access, Excel.

Confidential, NJ Dec'09 to Nov'10
SAS Analyst
Confidential, America's Most Convenient Bank®, is one of the largest banks in the U.S., and offers a broad array of retail, small business and commercial banking products and services. The project was based on Moneyline overdraft (OD) facility that bank offer which is an important facility subject to a pre-arranged limit, to the chosen customers based on the norms of bank. It is a formal arrangement with a bank that allows an account holder to draw on funds in excess of the amount on deposit.
Responsibilities:

• Designing, developing and testing a series of SAS programs for generation of data sets automatically without giving parameters from outside.
• Importing data using SAS/ACCESS in order to extract data from different relational database management (ORACLE and SQL SERVER) systems using SAS.
• Prepared new datasets from raw data files using Import Techniques and modified existing datasets using Set, Merge, Sort and Update, Formats, Functions and conditional statements.
• Deriving datasets with new columns for generating reports
• Maintained large data sets, combined data from various sources to create SAS data sets and/or ASCII files by using Set and Merge for generating Reports and Graphs.
• Developing macros for automatic running of all programs like Merging, Sorting, Printing of ODS files etc
• Creating SAS code to clean the invalid data using SAS Macros and SQL procedure.
• Sorting, printing and summarizing the datasets to modify and combining SAS datasets using sort procedure, set and merge concepts.
• Finding Null Values and deleting the invalid entries from the data
• Deleting Duplicate values form the data to get accurate results
• Developing reports using Proc Report, Proc Tabulate, Proc Freq, Proc Means.
• Generated the reports in desired output format (HTML, PDF and RTF format files)for decision making using SAS ODS (OUTPUT DELIVERY SYSTEM)
• Proc report was used to create Listings and Reports by customer, transaction key and account number.

Environment: SAS/BASE 9.1.3, SAS/MACROS, SAS/SQL, SAS/ODS

Confidential, NJ Oct'08-Nov'09
SAS Programmer
Confidential, through its subsidiary, Confidential, operates as a contract research organization in the United States. It engages in the business of providing integrated services across the drug development spectrum. The company focuses its services in the areas of biostatistics, data management (EDC, Hybrid, and Paper), CDISC consulting, medical writing, monitoring, regulatory, drug safety, and related training programs. Project was on statistical analysis and analysis support for Phase I and IV clinical studies.
Responsibilities:

• Generated SAS programs for pre-processing data, data analysis and for generating reports.
• Imported and Exported data files to and from SAS using Procedures like Import and Export from Excel , various delimited text based data files such as .TXT (tab delimited) and .CSV (comma delimited) files for data analysis.
• Exporting data files in various desired output formats by using SAS ODS and creating HTML, RTF, and PDF files in the process of producing reports
• Used SAS DATA _ NULL_ and PUT statements to generate the customized reports.
• Generated SAS programs and created macros for Biostatisticians to produce clinical trial deliverables like analysis datasets, tables and figures, patient data listings, and customized reports and validated them using Proc Compare and other procedures
• Validated SAS programs to create analysis datasets and other output tables by independent SAS programming and involved in testing and debugging against the test data.
• Acquired knowledge about documents related clinical trials like clinical protocol, SAP, Clinical Study Report and aCRF (Annotated CRF).
• Created SAS views from Oracle database tables using SAS/ACCESS and writing SAS code using BASE SAS and SAS MACROS to create SAS reports.
• Generating SAS programs for creation of tables, listings and analysis datasets for validating the original programmers output.
• Reviewed Protocols and provided Listing and Tables as per Statistical Analysis Plan.
• Performed Edit Checks on the data received from Data Management.

Environment: SAS9.1.3,SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/ACCESS, Microsoft Office Applications, Windows 2000, Windows NT, UNIX.

Confidential, MA Jul'07 to Sep'08
SAS Programmer
Confidential is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that deal with unmet medical needs in the acute care environment. The project involved Data analysis of Phase II Open Label Pilot Trial of Empiric Daptomycin Treatment for Oncology Patients with Neutropenic Fever for generation of CDISC SDTM Compliance Datasets, safety and efficacy reports (Tables and Listings).
Responsibilities:

• Involved in creation of Analytical Dataset, Generation of SDTM Compliance SAS Dataset, Generation of Tables and Listing, Validating, Mapping and conversion of Non- CDISC SDTM Dataset to CDISC SDTM Dataset as per SDTM IG 3.1.1
• Analytical Dataset (VS, MH, AE etc.,) creation as per ADS Specification, Data Quality Check and Validation
• Developing programs to generate SDTM datasets from raw data collected on Case report forms using CDISC standards.
• Experienced with the CDISC SDTM and ADaM models and transforming raw data into these standards.
• Creation of Safety and Efficacy Evaluation Tables and Listing as per Statistical Analysis Plan
• Tables and Listing Validation as per the Standard Operating Procedure (SOP)
• Document and Analyze results and set up reports containing respective conclusions, ideas and general guidance
• Reviewing data definition tables for SDTM and derived data sets for assigned studies and provide comments.
• Provided programming support to produce CDISC compliant databases (e.g. STDM, ODM, ADAM) for regulatory submissions
• Creating Annotated CRF's and generation of SAS Reports for Project Team Lead review

Environment:SAS9.1.3,SAS/BASE, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS/ACCESS, Microsoft Office Applications, Windows 2000, Windows NT, UNIX.

Confidential, India Jan'06 to Jun'07
SAS Programmer/Analyst Clinical Trials
Confidential is an emerging global pharmaceutical company. It is fully integrated company which produces and delivers safe, innovative, and high quality finished dosage forms, active pharmaceutical ingredients and biological products. Project involved developing SAS programs for various analyses in Phases I, II and III of Clinical Trials.
Responsibilities:

• Understanding study Protocol, SAP, CRFs. Retrieving the CRF data in to SAS from the ORACLE (CRF databases) using SAS/ACCESS and SAS SQL procedures.
• Generated graphics for reporting purposes using SAS/GRAPH, Proc Tabulate, etc.
• Created ad-hoc reports using various SAS Procedures, SAS/GRAPH and SAS/STAT for the functional specification.
• Involved in data manipulation by merging, appending, concatenating, sorting datasets and also data migration from one platform to another to be used for further clinical analysis.
• Extensively used Data _Null_, Proc Freq, Proc Tabulate, Proc Report, Proc Means, Proc Summary, Proc Contents, and Proc Compare.
• Investigated missing data and data inconsistency in SAS data sets. Developed edit-check programs to clean invalid data from the database.
• Created external files mainly RTF and HTML reports using SAS Output Delivery System (ODS).

Environment: SAS/Base, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS SQL, SAS ODS, ORACLE, UNIX.

Confidential, India May'05-Dec'05
Clinical SAS programmer
Confidential is a full-service Contract Clinical Research Organization and a complete business solution providing R & D services and offers the most advanced training in varied types of industry relevant courses. Data analysis involving Creating Analytical Datasets, Generating SDTM Compliance SAS Datasets, Tables and Listing, getting familiar with the highly regulated pharmaceutical industry, applicable Standard Operating Procedures (SOPs) and programming standards
Responsibilities:

• Reading and understanding the study annotated Case Report Forms, Study Definition documents, software tools and working with SAS
• Worked closely with programmer to gain experience in providing SAS programming support during the conduct and reporting phases of a clinical trial
• Assisted in the production of tables, listings and figures (TLFs) using macros, standard templates and custom SAS code and involved in the quality control of the TLFs and documenting the outcome of the testing according to the SOP
• Read and understood assigned documents, completed intern training and attended meetings as required. Became familiar with the methods of gathering clinical trial data and the Oracle Clinical data base structure
• Importing and exporting raw data files, manipulate and transform data, combine SAS data sets, create basic detail and summary reports using SAS procedures and handling errors by identifying and correcting data, syntax and programming logic errors.

Environment: SAS/Base, ORACLE CLINICAL, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS SQL, SAS ODS, ORACLE, UNIX.

EDUCATION:

• Master of Science in Biotechnology.