SUMMARY

• SAS Programmer with 7 years of experience in analysis, design, development, testing and validation
• Experience in providing statistical support for clinical studies, including design of studies, selection of appropriate statistical methodologies - Test, randomization, statistical analysis, and interpretation of results
• Individually capable of developing new SAS programs and/or enhancing existing ones from protocols and SOP
• Experience in reviewing case report form CRFs/SDTM/Adam to ensure that the protocol objectives are met and the project standard are maintained.
• Exposure to CDISC standards and GCP Guidelines
• Create project specific macros and formats.
• Involved in writing and updating project specific documents for reviews and approvals.
• Highly motivated individual with excellent organizational and interpersonal skills
• Possess strong ability to quickly adapt to new applications and platforms.
• Good team member with strong analytical and communication skills

TECHNICAL SKILLS

Business Intelligence Tools: SAS 9.x/8.x, SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH

RDBMS: Oracle 10g/9i/8i, SQL Server2005/2000, DB2 and MS Access.

Programming Languages: C, Java, SQL, PL/SQL

Web / Scripting: HTML, JSP XML, Java Script

Operating Systems: Windows 95/98/2000 Server, XP, NT, 2003 server and UNIX

PROFESSIONAL EXPERIENCE

Confidential, Hartford, CT

Sr SAS DEVELOPER

Responsibilities:

• Co-worked with Statisticians as a primary SAS programmer to analyze initial data sets and create tables, listings and figures (TLFs) for clinical trials.
• Created tables, graph to generate clinical study reports for the collected requirement from the statisticians referring to the Statistical Analysis Plan (SAP).
• Extracted data from ORACLE database and involved in cleaning the data (data cleansing) using various edit check techniques.
• Used procedures like PROC TRANSPOSE, PROC SORT, etc in Data transformation and Manipulation processes.
• Extensively used Proc SQL, Proc Transpose, Proc Format, Proc Means, Proc Univariate, Proc Freq, Proc Printto and Proc Compare for checking the assumptions and conducting Statistical Analysis.
• Effectively developed SAS code for modeling data and implemented SAS/STAT procedures such as Proc Lifetest, Proc lifereg, Proc Phreg, proc reg and Proc Glm for Survival analysis, logistic regression analysis and other statistical analyses.
• Produced Ad hoc reports of various kinds like Listings, Tables, and Figures (TLGs/TLFs) using Proc Report, Proc Tabulate, Data Null technique, Proc Gplot etc.
• Used SAS ODS to report outputs in different formats like RTF, PDF, and HTML
• Validated analysis data sets and SAS outputs with other programmers’ outputs and mockups in SAP using PROC COMPARE, PROC CONTENTS, and PROC FREQ.
• Created formats for the coded data and used PROC SQL for data validation.
• SAS macros were successfully used to create new programs and modified existing SAS programs to make them portable as well as for consistency of results.
• Documented, summarized and recorded data as per standard operating procedures (SOPs) and FDA regulations.
• Majorly worked with the data management team and was involved in handling documentation and submission processes (under managers’ assistance).

Confidential, Salt Lake City, UT

SAS ANALYST

Responsibilities:

• Responsible for providing Clinical SAS programming and analysis support for clinical studies across multiple protocols for the submissions like CSR and Safety.
• Generated Tables, Listings and provide QC check, validation of outputs for Oncology clinical trials.
• Responsible for developing reports for Safety and efficacy as per study requirements.
• Involved in Developing, Debugging, and validating the project-specific SAS programs to generate derived SAS datasets, summary tables, and data listings according to departmental standards.
• Used Sorting and Merging techniques on the raw data sets for value added data preparation, to get the required Reports or Analysis data sets.
• Performed QC (Quality Check) extensively on tasks performed by other team members and involved in data validation and data cleaning in all phases of Clinical studies.
• Extensively used Proc SQL to retrieve, update and report on information from SAS data sets and other database products.
• Modification of existing SAS programs and creation of new programs using SAS Macros.
• Built Macros and create macro variables using %LET, CALL SYMPUT, and DATA NULL to help generate analysis data sets and create specified structure of TLFs.
• Ability to quickly debug SAS compiling errors, to review SAS code and quickly identify areas of concern.
• Worked with Statisticians and Clinical Data Managers to provide SAS programming in analyzing the Clinical Trials and generating Reports.
• Created analysis datasets based on the guidelines provided in the Data Definition Tables (DDT) and following the CDISC standard. Used SDTM model (3.1.1)/ ADAM for domain creation and CDISC compliant analysis datasets.
• Used Proc CDISC for verifying compliance of datasets with CDISC standards and electronic submissions.
• Worked on multiple protocols and/or drug compounds at a time.

Confidential, Orchard Park, NY

SAS ANALYST

Responsibilities:

• Generated statistical analysis files, tables, listings, and graphs for Phase III drug trial studies.
• Collaborated with Statisticians, Data Manager, and other SAS programmers to provide ad-hoc and routine analyses and reports with regards to the assigned projects.
• Support Data management in data creation/transfers and integrity checks
• Imported external files like Excel files, text files, and Database files into SAS data sets using INFILE, LIBNAME, PROC IMPORT, SAS/Macros, and SAS/Connect, etc.
• Worked with different clinical trials data like Demographic, Medical History, Vital signs, Adverse Event (AE), physical examination.
• Created SAS data sets by extracting data from various sources and prepared them for statistical analysis. Manipulated data sets by using RETAIN, ARRAY, DATA NULL, SAS Functions, etc.
• Used Sorting and Merging techniques on the raw data sets for value added data preparation, to get the required Reports or Analysis data sets.
• Created Summary Reports and Tabular Reports using Proc Report and Proc Tabulate.
• Written custom safety and efficacy reports by directing SAS output to RTF and HTML files using SAS/ODS.
• Ensured analysis data and programming code meet regulatory and company standards (FDA and ICH regulations) and are consistently structured to permit efficient programming and reporting.
• Cross-validated programs with others: compared outputs and proofread the coding.

Confidential, Livingston, NJ

SAS ANALYST/DEVELOPER

Responsibilities:

• Data manipulation on SAS data sets using techniques such as merging, appending, concatenating and sorting.
• Imported huge data in to SAS library and sorted according to the class of the drug using ORDER BY option.
• Responsible for initial exploratory analyses, checking assumptions for required tests.
• Produced outputs in different formats such as HTML and PDF and using SAS/ODS.
• Checked and cleaned data through coding as according to the Standard Analysis Plan.
• Generated tables, listings, and graphs as per the SAP.
• Cross-verified the imported data in SAS with eCRF.
• Worked with clinical data management manager regarding data errors and related issues.