Professional Summary:

• SAS Certified Base Programmer with over 6 years of professional experience in SAS with strong emphasis on SAS programming, reporting, data analysis and data manipulation in Pharmaceutical industry.
• Good experience in analyzing case report forms (CRF) data, clinical trial data analysis, validation and documentation, generating reports an d summary tables, listings and graphs as per Statistical Analysis Plan (SAP) and protocol specifications.
• Strong emphasis on SAS V8/V9, SAS/BASE, SAS/Macros, SAS/SQL, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ASSIST, SAS/ODS, SAS ENTERPRISE GUIDE.
• Extensive experience with the SAS programming and in data step and with various SAS Procedures in Base SAS and SAS/Stat, including thorough knowledge of SAS Macro Language.
• Extensive SAS programming experience in four phases of Clinical Trials.
• Wide-range of experience in Data Manipulations using SAS data step statements such as, SAS formats/informats, merge, data _NULL_, set, functions and conditional statements and prepared statistical summaries and reports.
• Skilled in SAS Programming, Merging SAS Data Sets, Macro Facility, Preparing Data, Producing Reports, Validating Reports, SAS Formats, Storing and Managing Data in SAS Files.
• Knowledgeable in different data domains such as demographics (DM), concomitant medications (CM), vital signs (VT), lab (LB), adverse events (AE & SAE), protocol deviations (PV), medical history (MH) etc.
• Good knowledge of coding adverse events and concomitant medications datasets with MedDRA and WHODrug dictionaries.
• Excellent Experience in exporting SAS Results to different formats, Such as PDF, RTF, HTML and Excel Using SAS/EXPORT, SAS/ODS for Reporting and Presentation.
• Involved in creating SAS transport files for FDA Submissions.
• Experience in creating all deliverables and documentation in compliance with FDA regulations, 21 CFR Part 11, ICH and other regulatory standards.
• Good working knowledge of Microsoft Office, Internet applications and Electronic mail.
• Good analytical, problem solving, communication and interpersonal skills, with ability to interact with individuals at all levels.
• Ability to work independently and in a team proactively with excellent communication and organizational skills.

Technical Competencies:

SAS Tools : SAS 8/9.1.3/9.2, SAS/MACROS, SAS/ACCESS, SAS/BASE, SAS/GRAPH, SAS/ODS, SAS/SQL, SAS/STAT.
Operating Systems : Windows 95/98/2000/2003/XP/Vista/NT, UNIX, MS-DOS.
Languages : SAS, SQL, C, C++, MATLAB, HTML.
Databases : Oracle 9i/10g/11i, MS-Access.
Applications : Microsoft Office 97/2000/XP (Word, Excel, PowerPoint, Outlook)

Professional Experience:

Confidential, Abbott Park, IL May '11 - Till Date
Senior SAS Programmer

Confidential is a global health care company. It is principally engaged in the discovery, development, manufacture, and sale of a broad and diversified line of health care products along with pharmaceuticals, diagnostics and nutritional products.

Responsibilities:

• Have analyzed and processed the data in a SAS dataset to present the data in the form of a report.
• Extensively used SAS/ Macro facility to provide reusable programs that can be conveniently used time to time.
• Effectively performed data entry, conversions, and corrections.
• Maintained and enhanced existing SAS programs for deriving datasets, and for generating data listings, summary tabulation counts, categorical tables and listings.
• Efficiently utilized macros to eliminate repetitive SAS codes.
• Used sorting and merging techniques on the input data sets and used Proc Transpose for Data manipulation, to get the required output and then writing the code using SAS tools.
• Evaluated SAS codes for efficiency and scalability issues.
• Used the SAS Macro facility to produce weekly and monthly reports.
• Produced quality customized reports by using Proc Report, Proc Summary and provided descriptive statistics using Proc Means, Proc Freq and Proc Univariate.
• Established a validation process by the utilization of Proc Compare that saved both time and resources.
• Involved in designing, coding, testing and documenting SAS Programs/ Macros.
• Generated monthly extracts and quarterly extracts for the migration data by checking the data availability and created the reports.
• Performed weekly run by appending the data every week to get necessary data.
• Generated numerous ad-hoc reports on routine basis
• Maintained organized, complete and up-to-date study documentation, testing and validation/quality control documents and programs in compliance with company standards.

Environment: SAS/BASE, SAS/MACROS, SAS/STAT, SAS/ACCESS, SAS/ODS, WINDOWS, Unix and Teradata.

Confidential, Thousand Oaks, CA Mar '10- May'11
Senior SAS Programmer

Confidential discovers, develops, manufactures and delivers innovative human therapeutics. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses.

Responsibilities:

• Responsible for providing SAS programming and analysis support for Phase II clinical study.
• Prepared clinical data listings and summaries for statistical analysis and analyzed clinical data using SAS system.
• Integrated data from wide range of sources including in-house clinical data management systems, labs and contract research organizations and performdata cleaning with data steps and proc steps.
• Involved in importing and exporting of clinical data across a variety of applications to and from SAS.
• Used PROC SQL in coding concomitant medications data with WHODrug and medical history data was coded based on MedDRA.
• Created permanent formatted SAS data sets and used SAS/BASE and its modules for pre-processing data, data analysis and statistical analysis.
• Creating, documenting and maintaining project specific format library.
• Updated the formats catalog with necessary user-defined formats that are required to generate tables and listings.
• Extensively involved with verification and validation of reports based on company specific SOP and 21CFR Part 11 code of federal regulations for electronic submission.
• Written clear and comprehensible SAS codes using efficient methods.
• Involved in preparation and interpretation of table programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS), NDA and IND application for FDA submission.
• Produced reports in RTF, HTML and PDF formats using SAS/ODS facility.
• Computed several reports for safety and efficacy of the clinical studies, as per the specifications that were provided by the Statisticians.
• Performed program documentation on all programs, files and variables for accurate historical records and for future references.

Environment: SAS/BASE, SAS/ODS, SAS/SQL, SAS/STAT, SAS/MACROS, SQL, MS-Excel and Windows, My SQL.

Confidential, Berwyn,PADec'08 - Mar'10
SAS Programmer

Confidential is a privately-held pharmaceutical company that engages in the acquisition, development and commercialization of products for the treatment of cancer. Task involved working in analysis of phase I and phase II clinical trial data, producing tables, listings and graphs, electronic Submissions and quality control for clinical data.

Responsibilities:

• Successfully implemented statistical reporting processes for regular data collection and clinical data analysis. Analyzed Phase I and Phase II Clinical Trials data.
• Performed Data analysis, generated reports, listings and graphs using SAS Tools - SAS/Base, SAS/Macros, SAS/Graph, SAS/SQL, and SAS/Access.
• Worked in different clinical trail data domains such as demographics (DM), concomitant medications (CM), vital signs (VT), laboratory (LB), adverse events (AE), Serious Adverse Events (SAE), protocol deviations (PV) and medical history (MH).
• Involved in obtaining lab data online, transferring data into work sheets, and performed data audits.
• Created analysis datasets derived from raw CRF Data as per SAP.
• Extracted data from the Clinical databases and created SAS statistical analysis files for regulatory submission to FDA approval.
• Created and maintained statistical data sets using advanced data step procedures and manipulation techniques including arrays.
• Extensively used existing MACROS and developed SAS programs for data cleaning, validation, analysis and report generation. Tested and debugged existing macros.
• Produced accurate, precise tables and graphs for clinical Study Reports by conducting, documenting and reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR) Part11, FDA and other regulatory compliance.
• Created SAS Customized Reports using the DATA_NULL_ technique for FDA evaluations.
• Worked with Statisticians in generating SAS analysis datasets, production of data listings, summary tables, and statistical analysis.
• Use ODS statements and PROC TEMPLATE to create reports in style format.
• Used procedures like PROC TRANSPOSE, PROC SORT in Data transformation and Manipulation processes. Copied SAS datasets using PROC COPYutility.
• Implementation of QA techniques using Proc Freq, Proc Means, Proc Tabulate, Proc Univariate, Proc SQL and Proc Compare. Creating validation data sets, restructuring the patient's data, createdmacro's to check numeric, character and invalid data entries.
• Coding SAS programs with the use of Base SAS / Macros for ad-hoc jobs.
• Perform additional/ad-hoc SAS programming of data listings, summary tables and statistical analysis as required for clinical team review and data management staff.
• Responsible for creating summaries and listings for NDA submissions.

Environment: SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, WINDOWS and Oracle.

Confidential, Columbus, Ohio Aug'07 - Dec'08
SAS Programmer

Confidential is a Biopharmaceutical company developing products designed to improve the safety of the world's blood supply and is conducting Phase III clinical trials, designed to inactivate a wide range of viruses, bacteria and parasites, and has demonstrated its ability to remove proteins, while preserving the therapeutic properties of red blood cells. As a SAS Programmer, my role was in analysis of clinical trials data and generating required reports, listings, summaries and tables for submission to FDA and other regulatory authorities.
Responsibilities:

• Involved in SAS programming with Clinical Trials data for Phase III Clinical Trials.
• Reviewed protocol, case report forms (CRF) and responsible for Edit checks of clinical trial data to identify illogical data entries.
• Performed statistical analysis, written SAS programs for data management and reporting, and performed validation, including testing SAS programs
• Compared consistency of SAS variables, formats, and format codes across multiple studies
• Involved in creating various SAS Reports (Tables, Listings and graphs) satisfying the 21CFR-11 (Code for Federal Regulations) for electronic datasubmission.
• Extracted data from Oracle Clinical database using SQL Pass-Through facility and Oracle Libname Engine; converted data from excel spreadsheets to SAS DATASETS using PROC IMPORT, and imported CSV files into SAS datasets
• Convert MS-Word documents, MS-Excel, SQL tables into SAS data sets.
• Merging of data from multiple trials for generating integrated tables and resolving all merging issues.
• Applied interleaving, concatenating, merging, and appending techniques to SAS datasets while combining them.
• Implemented many flags to denote various Adverse events based on the requirements and as directed by statisticians.
• Created tables and listings to generate clinical study reports for the collected requirement from the statisticians referring to the Statistical Analysis Plan (SAP).
• Generated tables, listings, and graphs on Ad-hoc requests as per the requirements.
• Provide statistic analysis using Proc ANOVA, Proc GLM, PROC Logistic, PROC Corr and proc Univariate.
• Created reports using PROC REPORT for Adverse Events, Vital Signs and laboratory result as a part of safety measurement in RTF, PDF, Excel and HTMLstyle formats using ODS statements.

Environment: Base SAS, SAS/STAT, SAS/Graph, SAS/Access, SAS/Macros, SAS/ODS, UNIX, Oracle.

Confidential, India Nov'05 - Aug'07
SAS Programmer

Confidential is one of the fast growing pharmaceutical research companies with a focus in the field of developing Next-Generation Vaccines and Biopharmaceuticals through original and collaborative research. The objective of the application was to facilitate fast and accurate analysis of trial data, an immensely effective recombinant Vaccine for Hepatitis-B during the entire initial three phases and the future fourth phase.

Responsibilities:

• Involved in statistical analysis, reporting, and validation.
• Worked closely with Study Investigators to meet specific data analysis and reporting requirements.
• Analyzed the validated data to compute the following: Product compatibility, efficacy and safety of different pharmaceutical drugs, and drug distribution with other pharmaceutical drugs.
• Involved in clinical trials programming of data tables and listings for reporting on safety and efficacy.
• Developed efficient, well-documented, readily comprehensible and modifiable SAS code using SAS/Base and SAS/Macro facility.
• Maintained clinical trial data base, accessed various database to gather data, performed a table lookup and translated data values for meaning and readability.
• Performed data validation on the raw datasets and created the datasets for analysis.
• Extracting data from different data sources and creating SAS data sets.
• Converted MS-Word documents, MS-Excel, Oracle tables into SAS data sets.
• Responsible for developing new SAS programs and modifying existing SAS programs.
• Developed SAS programs using SAS/BASE mainly sorting, merging, and data validation.
• Developed SAS Macros for data cleaning and Reporting and to support routing processing.
• Compared consistency of SAS variables, formats, and format codes across multiple studies.

Environment: SAS/BASE, SAS/SQL, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, MS -Excel, Oracle and Windows.

Certifications:

• SAS Certified Base Programmer for SAS9.

• Bachelor of Technology.