Harshavardhan Bhimanapati

973-***-****

abmqwa@r.postjobfree.com

SUMMARY:

. About 6 + years of professional experience of SAS programming in

Clinical, Biotechnological, Pharmaceutical and Software Industries.

. Experience in SAS BI components - SAS Data Integration Studio, SAS

Enterprise Guide, SAS Enterprise Miner, SAS OLAP Cube Studio, SAS Web

Report Studio, SAS Information Map Studio, SAS Information Delivery

Portal, SAS BI Dashboard, SAS Management Console and SAS Add-In for

Microsoft Office

. Experience in back-end database such as Oracle, MS-Access, SQL Server,

Teradata, and DB2 .

. Extensive Experience in SAS/BASE, SAS/STAT, SAS/MACROS, SAS/SQL,

SAS/CONNECT, SAS/ACCESS, SAS/ODS, SAS/ENTERPRISE MINER, SAS/ENTERPRISE

GUIDE, SAS/ETL.

. Extensive experience in SAS/REPORT generating procedures like PROC

SUMMARY, PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC TRANSPOSE, PROC

FORMAT, PROC REPORT and PROC TABULATE etc.

. Good experience using SAS/GRAPH procedures, exclusively PROC GPLOT.

. Generated Reports, Tables, Listings, Graphs and Summaries as per

company standards and in compliance with 21 CFR Part 11, FDA, NDA and

other regulatory compliance.

. Interacted with senior Bio-statisticians and clinical data managers to

provide SAS programming in analyzing the data, generating reports,

tables, listings and graphs.

. Experience in SAS/ETL (Extraction,Transformation and Loading) with

Oracle/Access connectivity

. Worked on phase II, Phase III & phase IV Clinical Trials, performed

clinical data analysis and generated SAS datasets in accordance with

the SOPs and guidelines

. Experience in Integrated Summaries of Efficacy (ISE) and Safety (ISS)

according to Statistical Analysis Plan (SAP) and Protocol.

. Exposure to clinical trial data such as demographic data, Adverse

Events(AE), Serious Adverse Events(SAE), Laboratory data (Lab data)

and Vital Signs.

. Generated tables, listings, and graphs according to Statistical

Analysis Plan, Standard Operating Procedures (SOPs) and departmental

guidelines

. Performed data extraction from Databases and Flat files. Conversion of

SAS Datasets to various file types (including Excel, PDF flat files).

. Generated Output files in RTF, HTML and PDF using SAS/ODS

. Expertise in Code of Federal Regulations (21 CFR PART 11)

. Good Experience in CDISC processes such as SDTM, ADaM, ODM

. Good experience in working with different PK/PD documents

. Strong working knowledge of FDA regulations, ICH Guidelines and GCP

requirements.

. Ability to work on multiple tasks and strong interpersonal, analytical

and presentation skills.

. Excellent in analytical, presentation, communication and problem

solving skills and work independently as well as in a team

TECHNICAL SKILLS:

SAS Tools: SAS V8,V9.1,SAS/MACROS, SAS/SQL, SAS/STAT, SAS/GRAPH,

SAS/ACCESS, SAS/CONNECT, SAS/REPORTS,SAS/ODS,SAS Enterprise Miner, SAS

Enterprise Guide

SAS Procedures: Report, Print, Freq, Means, Summary, Univariate, Sql, Sort,

Transpose Contents, Options, Import, Export, Format, Anova, reg, Gplot,GLM,

TEMPLATE

Statistical Tools: SPSS, R, S-plus, Minitab, JMP,SPOT FIRE

Operating Systems: Windows 95/98/NT,XP 2000, UNIX.

Programming Languages: SQL, PL/SQL, MATLAB,BASIC C,ORACLE.

Web Technologies:HTML,DHTML,XML,ADOBE PHOTO SHOP

Office Tools:MS-OFFICE,MS-ACCESS,MS-WORD,MS-EXCEL.

EDUCATION:

Bachelors in Pharmacy, India.

CERTIFICATION:

Certified Base SAS Programmer For SAS 9.

WORK EXPERIENCE:

Millennium Pharmaceuticals, Cambridge, MA

Oct 09 - Present

SAS Programmer Analyst - Clinical Trials

Millennium Pharmaceuticals is a biopharmaceutical company developing

products designed to improve life of patients and is conducting Phase I to

Phase IV clinical trails, in wide range of viruses, bacteria and parasites,

and has demonstrated its ability to remove proteins, while preserving the

therapeutic properties. As a SAS programmer my role is in analysis of

Clinical trail data and generating required reports, listings and summaries

for submission to FDA.

Responsibilities:

. Performed SAS programming on SAS Base, Macro language. Used data

manipulation techniques, and statistical procedures (e.g., PROC

UNIVARIATE, PROC FREQ, and PROC REPORT, PROC TABULATE, PROC SQL, PROC

TRANSPOSE, PROC SUMMARY, PROC MEANS and DATA _NULL_ etc).

. Created SAS datasets to be used for the analysis programs.

. Extensively used SAS/ Macro facility to provide reusable programs that

can be conveniently used time to time.

. Modified UNIX scripting for SAS batch jobs in development.

. I have extensive experience in creating DEFINE.pdf formats in

submission of docs to FDA.

. Performed Data analysis, generated reports, listings and graphs using

SAS Tools - SAS/Base, SAS/Macros and SAS/Graph, SAS/SQL, SAS/Connect,

SAS/Access.

. Well versed in writing UNIX korn, bash shell scripts and scheduling

korn, at jobs for timely event trigger processes.

. Developed routine SAS Macros to create tables, graphs and listings for

inclusion in clinical study reports and regulatory submissions and

maintained existing ones.

. I have extensive experience in CDISC and SDTM.

. Experience in Integrated Summaries of Efficacy (ISE) and Safety (ISS)

according to Statistical Analysis Plan (SAP) and Protocol.

. I have Experience in Annotate CRFs in accordance with CDISC published

or sponsor specific guidelines with appropriate metadata to reflect

case report tabulation (CRT) data sets.

. 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)

Part 11, FDA and other regulatory compliance.

. Generated tables, listings and reports of Adverse Events (AE) and

Serious Adverse Events (SAE) and was also involved in validating the

programs of integrated summaries of safety (ISS) and efficacy (ISE).

Environment: SAS 9, SAS/BASE, SAS/MACROS, SAS/SQL, SAS/STAT, Oracle8,

Oracle Clinical, Windows NT and UNIX.

American Century Investments, Kansas City, MO

Nov 08 - Sep 09

SAS Programmer

American Century Investments is a privately held investment management

firm. Their major criterion is to serve investment professionals,

institutions, corporations and individual investors. More than 40 percent

of American Century Investments' profits support research to help find

cures for the genetically-based diseases including cancer, diabetes and

dementia. I was involved in performing complex analysis on the data.

Roles and Responsibilities

. Used PROC SQL Pass-through facility and Oracle DB Load procedure for

data transfer

. Created SAS views from the tables in Oracle database using SAS/ACCESS.

. Involved in the data transfer and data conversion from one platform to

the other (SAS to Oracle, Oracle to Excel) and the obtained data was

used for further analysis.

. Extensively used statistical procedures like UNIVARIATE, SUMMARY,

TABULATE, MEANS.

. Modified existing SAS programs using SAS/MACROS to improve the

performance and enhance the data quality and developed numerous

decision support reports in a distributive environment for the

management department.

. Manipulated data by using MERGE, APPEND, CONCAT, SORT PROCs and

generated the reports.

. Generated graphs using PROC GPLOT through SAS/GRAPH and the SAS

Graphic Editor.

. Developed efficient, well-documented, comprehensible and modifiable

SAS code for ad-hoc jobs using SAS/BASE and SAS/Macro facility.

. Validated data by checking data distribution and by comparing it to a

standard data.

. Ran SAS report programs to generate weekly/monthly/annual reports and

exported the results to Excel for further analysis.

Environment: SAS V8, SAS/BASE, SAS/MACROS, SAS/SQL, SAS/GRAPH,

SAS/ACCESS, SQL, PL/SQL, Windows 2003.

Client :Deloitte

End Client:Dept. of Services - Virginia's Community Colleges, Richmond, VA

Title: Sr. SAS/SAS BI Developer.

Dec 07 - Oct 08

Project: Student Success Predictive Model

Virginia's community colleges (www.vccs.edu) have a 40-year track record of

educational excellence and innovation to serve the needs of the citizens

and strengthen the Commonwealth's economy. The mission of the Virginia

Community College System is to provide comprehensive higher education and

workforce training programs and services of superior quality that are

financially and geographically accessible and that meet individual,

business, and community needs of the Commonwealth. The Virginia Community

Colleges Policy Manual is a living document that guides the operation of

all community colleges in the Commonwealth. The Chancellor and State Board

for Community Colleges continuously approve changes to spur innovation and

maintain the highest standards of performance across the system.

Roles and Responsibilities:

. User Interaction, Analyzed the business requirements, written the

functional specifications, design, development, verification,

technical/user documentation, training, and mentoring

. Created the ER Diagrams with TOAD from oracle database

. Created the SAS Data marts from Oracle Data warehouse

. Performed the ETL by using the SAS Data Integration Studio

. Written the macros, used the PROC SQL Pass through Facility and

written the complex SQL queries

. Proficient in the maintenance and analysis of large data sets

. Developed the Predictive models with SAS Enterprise Miner to find the

Student success/risk

. Created the OLAP Cubes with dimensions, hierarchies and measures by

using the OLAP Cube Studio

. Created the Information Maps by using the Information Map Studio

. Created the static and parameter driven Reports by using the Web

Report Studio

. Published the Reports to the SAS Portals

. Written and registered the Stored processes, worked on front end

development using JSP, HTML, Javascript

. Analyzed, generated the ad-hoc and regular reports for various levels

of users

. Performed peer reviews of work items produced at various stages of the

project

. Developed Test plans, Test cases, Executed and documented the testing

results

Environment: Base SAS 9.1, Macros, SAS/STAT, SAS Data Integration Studio

3.4, SAS Enterprise Guide 4, SAS Enterprise Miner 5.2, SAS OLAP Cube Studio

3.1, SAS Information Map Studio 3.1, SAS Web Report Studio 3.1, SAS

Information Delivery Portal 2.0, SAS Management Console, SAS Add-In for

Microsoft Office, SAS Stored process, SQL, PL/SQL Developer, Oracle 10g,

VSS, Documentum, TOAD, FTP, SunOS 5.10 platform, Java, JSP, HTML,

Javascript

Bristol-Myers Squibb Company, Princeton, NJ

Sep 06 - Nov 07

Sr. SAS Developer & Tester

Bristol-Myers Squibb (www.bms.com) is a global pharmaceutical and related

health care products company whose mission is to extend and enhance human

life. Bristol-Myers Squibb's 43,000 employees are dedicated to discovering,

developing and providing innovative medicines that address significant

medical needs of patients worldwide. And by living our mission and growing

our company for well over a century, we are also making a difference in the

lives of our shareholders, employees and neighbors.

Roles and Responsibilities

. Analyzed application requirements, provided recommended design and

created application from detailed specifications

. Developed and tested the Statistical Analysis and Reporting (SA&R)

Application in Unix environment

. Written the Stored processes, created detailed project outlines and

application design specifications

. Worked on front end development (GUI interfaces) by utilizing ODBC to

connect to the Open Architecture RDBMS (Relational Database Management

Systems) such as Oracle and Sybase

. Coded, tested, debugged, documented and maintained programs

. Used the PROC SQL Pass through Facility and written the complex SQL

queries

. Quality reviews of code developed by other development staff

. Developed Test plans and Test cases, Executed and documented the

testing results

. Reviewed data to verify integrity and consistency for completeness,

accuracy and suitability, including data adherence to protocol, data

coding integrity, reliability of collection and interpretation

. Created SAS programs according to requirements specifications and

followed SOPs to produce accurate and timely results

. Maintained organized, complete and up-to-date study documentation,

testing and validation/quality control documents and programs in

compliance with company standards.

Environment: SAS 9.1, SAS Macros, SAS/ODS, SAS ETL, SAS Enterprise Guide,

SAS Enterprise Miner, SAS Stored process, SAS/Graph, SAS/STAT, SQL, Oracle,

UNIX - Sun Solaris, SQL, VSS, Documentum, FTP, Java, JSP, HTML.

Vertex Pharmaceuticals Inc, Coralville, IA

Jan 06 - Aug 06

SAS Programmer/Analyst

Vertex Pharmaceuticals main aim is to transform the way serious diseases

are treated. Vertex's drug discovery platform has been highly productive

and is the source of key product opportunities in infectious diseases,

cystic fibrosis, inflammatory disease, cancer and other areas.

Responsibilities.

. Worked closely with the research team of scientists to analyze the

data, generate the reports, and list them according to

specifications.

. Involved in analyzing, writing clinical trial reports and presenting

clinical trial results.

. Generated the required SAS datasets from the database using sorting

and merging techniques.

. Performed Data conversions, Data corrections, Uploading/Downloading

the data.

. Developed and summarized clinical trials data using SAS/STAT

procedures such as PROC CORR,PROC REG, PROC ANOVA, PROC GLM and Data

step programming.

. Extensively used SAS procedures such as PRINT, REPORT, TABULATE, FREQ,

MEANS, SUMMARY and TRANSPOSE for producing ad-hoc, customized reports

and external files.

. Created Custom reports using DATA_NULL_ and PUT statements.

. Designed flowcharts indicating the input data sets and the techniques

that would be used (sorting, merging, etc) to get the desired output.

. Used SAS Macro functions to simplify the process and get consistent

results.

. Using SAS/Macros, reports were updated on a monthly basis according to

the schedule.

. Used SAS/ODS to create HTML, RTF and PDF outputs files in the process

for producing reports.

. Developed the programs for generating Efficacy (ISE) and Safety (ISS)

tables.

. Based on the specification document created CDISC-SDTM SAS datasets

following all the standards.

. Involved in creating transport files as per the CDISC standards for

electronic submissions to the FDA.

. Worked with validation team to validate the applications in compliance

with 21 CFR Part 11 and other FDA mandatory regulations.

. Reviewed study Protocol, Annotated Case Report Form (ACRF), and

performed validation of clinical trial data to identify illogical data

entries.

. Involved in data transmission and integrity checking of the existing

and in-house clinical trial systems.

Environment: SAS V8.2, SAS/BASE, SAS/STAT, SAS/ODS, Oracle 8i, SQL, MS-

Excel, Windows 2000, UNIX (Solaris).

Dr.Reddy's Labs,Hyderabad, India

Jul 04 - Dec 05

Software Analyst

Dr.Reddy's Labs is a leading research-based pharmaceutical company with a

broad pharmaceutical product line and wide variety of vaccine products,

over-the-counter (OTC) medicines, oral care products and nutritional

healthcare drinks. As an analyst, performed relevant statistical analysis

of administrative and automated claims databases, surveys and economic

data, captured during clinical trials. Performed quality control (QC)

checks against database to ensure correct data was entered.

Roles and Responsibilities:

. Responsible for data collection, management and manipulation of

clinical database

. Performed statistical analysis, written SAS programs for data

management and reporting, and performed validation, including testing

SAS programs

. Downloaded data from Oracle using SQL within SAS to be analyzed and

exported to Excel for further analysis

. Compared consistency of SAS variables, formats, and format codes across

multiple studies

. Created standardized datasets from the existing datasets

. Created validation programs to validate the standardized datasets

. Produced quality customized reports using various procedures

Environment: Base SAS, SAS/ Macros, SAS/Access, Oracle, SQL

Sara Pharmaceuticals, Chennai, India

Nov 03 - Jun 04

SAS Programmer

Sara Pharmaceuticals are pioneers in manufacturing parental products. The

innovation, knowledge and experience accumulated in organization are

pivotal for getting safe and efficacious drugs.It is one of the reputed

Biopharmaceutical companies in India and is involved in developing new

sterile products, vials,ampoules and also parentral allopathic formulations

in injections

Responsibilities:

. Worked on phase II and phase III clinical trials

. Produced derived data sets, listings, tables for data analysis

. Worked with statisticians and data managers

. Used various BASE SAS procedures such as proc print, proc mean, proc

freq, proc report

. Used SAS/ACCESS to import and export data to and from MS Access and

Excel

. Responsible for choosing appropriate statistical techniques relevant

for the analysis of data

. Used SAS/GRAPH to generate figures as per Statistical Analysis Plan

. Developed SAS programs to validate the data and used different

validation techniques such as proc univariate, proc mean, and proc

freq

. Export and import SAS datasets from and to excel

Environment: BASE SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/ACCESS, WINDOWS

NT, SAS V8,SAS/SQL, ANOVA, PL/SQL.

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