Summary of Clinical SAS experiences at a glance:

• 6 years SAS programming experience in the pharmaceutical industry.
• Sound knowledge in clinical trials, which includes clinical program code, review and evaluate , safety report, adverse
• event report reviews, integrated safety and efficacy summary and risk benefit for FDA submission, E-submission.
• Very good knowledge about all Phases of Clinical Trials in different Therapeutics areas.
• Hands on experience in the creation of case report tabulation data definition specification CRT-DDS/define.xml and experience in providing support in the development of an automation tool for the creation of define.XML and define. PDF.
• Intensive exposure to SAS Programming-Macro Facility used different SAS Procedures, Produced Reports Proc Report , SAS Formats and Informats, SAS Functions etc.
• Experience in understanding PROTOCOL, SAP, SOP and CRF.
• Experience in Preparation of SAS Datasets, Tables, Listings and Graphs according to Specifications, Protocol and Statistical Analysis Plan.
• Extensive experience in SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/ODS and SAS/GRAPH.
• Familiar with Code of Federal Regulations 21 CFR Part 11 and e-submission standards for FDA.
• Knowledgeable in CDISC standards data models .
• Created programs to validate datasets compliance to CDISC SDTM standards.
• Knowledge of Medical Dictionaries like MedDRA and WHO Drug.
• Hands on experience in creating datasets based on implementation guides IG of CDISC SDTM 3.1.1 and 3.1.2
• Specifications and ADaM.
• Working with Macros and Ad-Hoc Reporting.
• Working on Multiple Projects and under Tight Timelines.
• Excellent communication skills.

Technical Skills:

SAS Skills: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/MACRO, SAS/ODS

Database: Oracle, MS-SOL.

Tools: MS Office 95/XP/2003/2007, Sigma Plot, MS Excel, Image-J, Examin-IR Image analysis .

Operating System: UNIX, MS Windows 95, 98, 2000, XP .

PROFESSIONAL EXPERIENCE:

Confidential

Roles: SAS programmer

patients.

Developmental Responsibilities:

• Reviewed protocol, CRF and SAP for creating Metadata sheet and creating SDTM data set.
• Created metadata sheet from the CRF.
• Mapping the SDTM domain from the metadata Excel sheet.
• Created Analysis data set, Tables Listings using Base/SAS, SAS/STAT, SAS Macro, SAS/SQL and SA/ Report.
• .Produced reports using Proc Means, Proc Freq, Proc SQL and proc reports.
• Used ODS to produce reports in HTML and PDF and RTF.

Environment: SAS/BASE, SAS/Macro, SAS/SQL, SAS/ODS, SAS/Window and Excel.

Confidential

Roles : SAS Programmer

• Description : Percept Pharma Services is a leading service provider for pharmaceutical and Bio-Tech
• Compagnies. Percept Pharma provides specialized services and developing software for CDISC implementation.
• Project : This project was on the cardiovascular and infectious disease therapeutical area and e-submission to FDA.

Development resposibilities :

• Extensively programmed in SAS/Base, SAS/Macros, SAS/Stat, SAS/Graph, SAS/SQL and
• SAS/Report.
• Created SDTM datasets from legacy/ raw datasets.
• Develop, test, validate, implement and maintain SAS programs for the automation tool which creates the define.xml and define. PDF.
• Generate the Datasets and TLF's for the Regulatory Submissions.
• Created Programs to validate datasets CDISC SDTM compliance.
• Created standard TLG's for CSR for the clients.
• Reviewed Protocol, CRF, and SAP for creating Analysis datasets, Tables, Listings and Graph's using BASE/SAS, SAS/STAT, and SAS/GRAPH.
• Generated reports of standard analysis using Proc Report and data null and successfully handled missing data and dropouts using Last Observation Carry Forward and Worst Observation Carry forward logics.
• Designed and validated new and existing programs depending on the requirements.
• Produced reports using Proc Means, Freq, SQL, Report, and Summary.
• Used Output Delivery System ODS to produce HTML, PDF and RTF reports.
• Ensure the proper and timely delivery of ad-hoc reports as required.

Environment: SAS/Base, SAS/SQL, SAS/Marco, SAS/ODS, SAS/Graph, SQL/Windows, Excel.

Confidential

Roles: SDTM Developer/Programmer

• Description: Eisai is a US Pharmaceutical Subsidiary of Tokyo Based Eisai Co. Ltd, a research based human
• Health Company that discovers develops and markets the products throughout the world.
• Projects: Oncology Data Management
• Developmental Responsibilities: Responsible for the design and documentation of all the
• Domain/Dataset Content including,
• Involved in SAS programming for Clinical trials in Oncology and e-submission to FDA.
• Reviewed protocol and Case Report Forms to identify errors of the clinical trial data.
• Developed specifications for SDTM conversion and mapping programs.
• Involved in Mapping and Integrating study data to a CDISC-compliant proprietary analysis data system.
• Validation all the tables and listings using validation rules in programing SOP's.
• Attended content reviews/workshops for respective Domains/Dataset per assignment
• Participated in weekly meetings with team lead to discuss about work progress and quires regarding project.
• Design and develop standard SAS macro for SDTM domains.

Environment: SAS 9.3 version, SAS/base, SAS/macro, SQL, MS Office, Excel, Windows

Confidential

Domain: Clinical

Role: SAS Developer.

Responsibilities:

• Involved in phase I, Phase II and Phase III clinical trial data.
• Developed SAS program to load data from source and created study specific datasets, which are used as source data sets for report generating programs.
• Used various procedures like Proc print, Proc Report, Proc Means, Proc Compare, Proc Transpose, Proc Tabulate, Proc Freq, Proc Summary, Proc Sort, Proc SQL, Proc Univariate and Proc Content in the programing.
• Developed SAS Macros to improve the consistency of results.
• Generated tables, Listings and graphs for clinical study reports.
• Generated ad-hoc listings using Proc Print, Proc report, Data null and Proc Sql.
• Worked with Bio-Statisticians, Data Managers and Clinical Research managers as required.

Environment: SAS version 9.1, SAS/Macro, SAS/Base, SQL, MS Office, UNIX

Confidential

Role: Working as research specialist D in the Department of Diabetes, Endocrinology and Metabolism.

• Contributions: As Technical Director of the Mouse Physiology and Metabolism Core I have provided core services to the University of Pennsylvania and outside Penn investigators.
• This includes the accessing the insulin sensitivity by Hyperinsulinemic Euglycemic Clamp, Glucose Tolerance Test, Insulin Tolerance Test, indirect calorimetric studies by CLAMS system, to find out which fuel is used by the mouse, NMR and DEXA scans to access the lean and fat mass in the body.
• Developed protocol for treadmill exercise for mouse.
• My studies on diabetes have led me to create a thermography technique for my specific lab, department and outside clients as well. This technique involves using a specialized camera to detect levels of heat in an animal by imaging. Furthermore, the different colors in the image can be converted to tangible temperature values, which allow us to study the results with concrete values and numbers. This technique has been very useful to study the heat map of the mouse, which gives the surface temperature of the mouse near brown fat in the body. Such information can give us information on the activity of the mouse such as the amount of fat a mouse is burning, the activity of a tumor and how well the mouse can maintain its body temperature.