BHARATH
*******@************.***
BHARATH
________________________________________________________________________
EXPERIENCE SUMMARY:
> Over 6 years of experience in IT as a SAS Programmer/Analyst with
profound experience in Pharmaceutical and Health Care Industry.
> Expertise in BASE SAS programming, SAS/Macros programming and
debugging, experience in the skills in SAS/BASE, SAS/BI, SAS/MACRO,
SAS/SQL, SAS/ETL, SAS/DW, SAS/GRAPH, SAS/ACCESS, SAS/CONNECT, SAS/ODS.
> Good expertise in extracting data sources from other environments to
SAS using SAS/ACCESS
> Experience with complete new Drug & Device release process from IND
submission to FDA approval, in compliance with 21CFR Part 11, which
includes Clinical Trials (Phases I-IV), preparation of IND, NDA,
safety reviews, adverse event report reviews, integrated safety and
efficacy summary (ISS & ISE) for FDA submission.
> Experience in using different relational database management systems
like DB2, Teradata and Oracle.
> Experience using SQL (including T-SQL, PL/SQL of Stored Procedures,
Stored Functions, Views) for simple to complex data manipulation or
report generation.
> Fair knowledge of Object oriented concepts, posses working knowledge
of Core Java.
> Experience working on different operating systems (Unix, Windows,
Linux)
> Experience with regression analysis, correlation analysis and analysis
of variance on clinical trial data.
> Created and customized Macros for use in data cleaning,
initialization, creation of analysis, datasets and report generation
for FDA submissions.
> Experience in creating test scenarios to find errors and confirm
programs meet specifications. Program Documentation and Review.
> Thorough Knowledge and experience of Microsoft Office tools like MS
Access, MS word, MS PowerPoint, MS Excel, Lotus Notes, Microsoft
Outlook.
> Excellent communication, analytical, interpersonal, presentation and
problem solving skills.
> Highly motivated and goal achiever individual.(
TECHNICAL SKILLS:
Statistical SAS 6.x, 8.x, 9.1.3, 9.2 (Base SAS, SAS/STAT, SAS/SQL,
Packages SAS/MACROS, SAS/GRAPH, SAS/ACCESS, SAS/ODS).
Databases Oracle 9i, Oracle 10g, Oracle 11g, DB2, Teradata.
Languages C, C++, SQL, PL/SQL
Platforms Windows 9x/NT/2K/XP, DOS, UNIX, LINUX.
Others MS office, VBA macros.
EDUCATION:
> Bachelor of Pharmacy
WORK EXPERIENCE:
Novosys Health LLC, Flemington, New Jersey
Jul'10 - Present
SAS Programmer/Analyst
Novosys Health provides premier quality research in health economics and
outcomes research that helps quantify and demonstrate the full value of
pharmaceutical and other medical products. We help to use real-world data
to illustrate the clinical and economic benefits and values of healthcare
products to payers, clinical providers, patients and policy makers.
Responsibilities:
> Utilized SAS/ACCESS to extract data from Oracle and other relational
databases for analysis
> Prepared new datasets from raw sets files using Import Techniques and
modified existing datasets using data statements such as SET, MERGE
and PROC SORT
> Extensively used PROC REPORT and PROC TABULATE to create reports
> Generated safety tables, which also involved in analyzing data and
generating Reports
> Created reports using the DATA _NULL_ and the PROC REPORT for the
submission as per the FDA regulations and company standards
> Validated SAS data sets using PROC MEANS, PROC FREQ and PROC
UNIVARIATE
> Formatted HTML, RTF and PDF reports using SAS output delivery system
ODS
> Worked with automation team to automate the reports using SAS/DDE and
VB macros.
> Raw Data is imported in to the SAS library and sorted according to the
class of the drug using ORDER BY option
> PROC MEANS is applied on the data to determine the statistical
variables for the data
> A combination of PROC SORT and PROC SUMMARY by CLASS are used to
produce a sub-sorted output
> Used PROC SQL for querying and reporting
> Developed new SAS programs to load data from the source and create
study specific datasets, which are used as source datasets for report
generating programs
> Prepared extensive summary for clinical data research data.
> Performed quality control checks on tables, listing etc generated by
other team members
Environment: SAS/BASE, SAS/MACRO, SAS/CONNECT, MS-Excel, ORACLE, Windows
XP, Visual Basic
Access Pharmaceuticals, Dallas, TX
Oct'08 - Jun'10
SAS Programmer/Analyst
Responsibilities:
> Member of programming team that developed a suite of SAS applications
to meet needs of Clinical project.
> Analyzed business requirements with multiple and various user's
community, carried out various analyses and wrote application
specifications.
> Maintained and coded SAS programs for evaluation and validating of
incoming clinical data.
> Coded and tested SAS program to create Clinical Summary Reports.
> Performed diverse analyses, coded and tested SAS programs using Proc
Tabulate, Proc Report and Data _Null_.
> Employed techniques like sorting and merging on the raw data sets and
coded them using Proc SQL and SAS Macro facility to get the required
output.
> Created SAS datasets from Microsoft Excel files using Proc Import and
Import Wizard.
> Used SAS Macros and procedures like Proc SQL, Transpose, Univariate,
Means, Freq
> Performed statistical analysis using One-Way ANOVA.
> Used Proc GPLOT, Proc GCHART for graphical presentation of the data in
the form of Bar Charts, Pie Charts and Scatter Plots.
Environment: Base SAS, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/AF, MS-
EXCEL, SPSS, OraReviewed SDTM data according to CRF protocolcle 8, HTML.
Amarillo Biosciences, Amarillo, TX
Jun'07 to Oct'08
SAS Programmer/Analyst
Responsibilities:
> Prepared, processed and analyzed clinical data required for analysis
of clinical trials for Phase I studies with SAS programming. Data was
collected in CRF and sent to us as raw data.
> Conversion of Existing Raw data into CDISC standards and review CRFs
to ensure consistency with protocol and adequacy in collecting data to
meet objectives defined in protocol.
> Interacted with data management team to understand the data and
clarified the queries
> Extracted and maintained SAS data sets from the raw data created by
the data management group.
> Supporting, designing and development of SAS and Excel/VBA based
reporting solutions. Quality review, auditing and exception
handling/management
> Integration with the production environment and business process
components
> Modified to SAS modules, modification to Excel/VBA-based front-end
templates.
> Provided mapping specifications for various mapping projects.
> Reviewed SDTM data according to CRF protocol and annotated CRF
according to SDTM variables.
> Prepared tables like subject disposition, Laboratory summary and
Pharmacokinetic Parameter (AUC 0-inf, AUC 0-t, T-half, Cmax, etc.)
Summary
> PROC SUMMARY, PROC MEANS, PROC TABULATE is used for report generation.
> PROC SQL is used for querying and reporting.
> Provided SAS programming and statistical support to the clinical
studies.
> Assisted in validation, edit checks and data review listing.
> Created Summary Reports and tabular reports using Proc Report.
Environment: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/GRAPH, SAS/STAT, Windows,
MS Excel, SPSS.
Dr. Reddy's Laboratories, Hyderabad, India.
Apr'05 - May'07
SAS Programmer/Analyst
This company is one of the largest manufacturers of generic pharmaceutical
products with more than 200 products ranging across many therapeutic drug
categories such as anti-infective, anti-arthritic, cardiovascular,
gastrointestinal agents and psychotherapeutic. As an analyst, I involved in
the Clinical data analysis and the creation of reports by extensive use of
Base SAS, SAS/Macro and SAS/Graph.
Responsibilities:
> Raw Data is imported in to the SAS library and sorted according to the
class of the drug using ORDER BY option
> PROC MEANS is applied on the data to determine the statistical
variables for the data
> A combination of PROC SORT and PROC SUMMARY by CLASS are used to
produce a sub-sorted output
> Used PROC SQL for querying and reporting
> Developed new SAS programs to load data from the source and create
study specific datasets, which are used as source datasets for report
generating programs
> Developed reports using PROC REPORT, PROC TABULATE and DATA _NULL_
> Created flow chart and process flow diagrams for the whole process
> Flow diagrams and Graphs were compared to analyze the market trend of
the particular drugs
> Reports are submitted annually to the Vettar Group
Environment: SAS, SAS/SQL, SAS/MACROS, SAS/BASE, SAS/ACCESS, Oracle 7.3