Data Oracle

Srinath Bosula

(Senior SAS Programmer/Analyst)

Phno: 510-***-****

Email: ********@*****.***

SUMMARY

Senior SAS clinical trials programmer with over 7 years of experience at, major pharmaceutical companies (like Pfizer, Bristol-Myers Squibb) and

CRO’s. Experienced in producing data listings, statistical and summary tables and figures to support NDA applications (Phases I – IV)

Experience using interactive clinical trial applications to report clinical trial analyses

SAS modules used: Base SAS, advanced macros, ODS, Access, Stat, Graph, SCL and AF

Additional experienced using Oracle Clinical, data warehousing and e-commerce applications

SOFTWARE / HARDWARE

SAS/Clinical trials, SAS programming using tools- SAS V6.12, SAS V8 (Base SAS, SAS/Stat, SAS/Macros, SAS/Access and SAS/Graph), Oracle

Clinical, Oracle, DB2, MS SQL Server, MS-Access, Excel, PL/SQL, Java (1.2/2), PL/SQL, PERL, C, C++, Cobol, Pascal, EJB, Servlets, JSP, JDBC,

ASP, HTML, XML, Power Point, JavaScript, RMI, AWT, SWING, JMS.WebMethods3.6, BEA Weblogic5.1, Web logic Commerce Server2.0.1, Java

Web Server, JRun, Internet Information Server (IIS), Visual Basic 5, Developer – 2000, Visual Café 4.0, Jbuilder4.0., Crystal Reports, Windows

NT/98/95, UNIX, DOS

PROFESSIONAL EXPERIENCE

Sr. SAS Clinical Programmer/Analyst – FEB’08 -- Current

Gilead Sciences, Inc., Biopharmaceutical

Responsibilities:

1. Using Perl script down load the data from EDC Vendors.

2. Involved writing edit checking specs and programs.

3. Involved creating Standard safety listing and Patient Profiles and Patent Narrative Reports.

4. Working with Local lab data and Covance lab data, adding Lab Normal Ranges and Unit Conversation and Toxicity grading to Local lab

data and merging both local and Covance lab data.

5. Involved Creating Lab reports, like Missing CRF Page Report, Excepted Lab tests,

And unexpected lab test Reports.

6. Creating Analysis datasets on CDISC,SDTM standards.

7. Involved Creating CRT-DD file using XML.

• Using PK Concentration data and CRF data, creating PK Dataset..

• Using PK data, Involved PK parameter calculations(Cmax,Tmax,Clast,Tlast,Ctau,T1/2,AUC,Cave) and Generating TFL.

Environment: UNIX, SAS 8.2/9.13, XML, PERL, Base/Stat/Graph/Macro/Access/Connect, RDBMS, EDC.

Sr. Statistical SAS Programmer/Analyst -- JULY’07 – JAN’08

Pfizer Pharmaceuticals, CPW

New London, CT.

(Tele-commuting).

Responsibilities:

1. Working with Clinical trial data Concomitant/Previous Medication, Concomitant/

Non-drug treatment and pain study.

2. Worked with validation team to validate the applications compliance with 21 CFR part 11 & other FDA mandatory regulations.

3. Interacted with Biostatics team and documentation team for QC and FDA Guidelines.

4. Developed summarize clinical trials data using SAS/STAT procedures and data Step programming.

5. Integrated Clinical and Statistical reports, NDA summaries, ISS and ISE Documents, Annual reports.

6. Developed programs for derived datasets.

7. Creating basic statistical and regression analyses PROC FREQ, PROC ANOVA, PROC ANOVAC, PROC LIFETEST, PROC MIXED.

8. Developing generalized utility macros to automate programs for standard reports and validations

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9. Involved in listing, summary, tables using different SAS/reporting tools like Proc Report, Proc tabulation and data_null_ as per the

requirement.

10. Working with ODS, PROC REPORT to generate PDF, RTF files.

11. Creating Bar charts using PROC GCAHRT and PROC GREPLY to generate multiple graphs in one page.

12. Working on CDSIC standards.

Environment: UNIX, SAS 8.0 Base/Stat/Graph/Macro/Access/Connect, RDBMS, oracle clinical

Sr. Statistical SAS Programmer/Analyst ---May’06 –June ‘07

Scios Inc.

Freemont CA

Scios’ mission is to develop drugs and treatments that change the way chronic and serious diseases are treated. Inter weaving classical molecular

chemistry with the most recent advances in disease-based gene array, bioinformatics and computational chemistry.

.

Responsibilities:

1. Working with Biostat team on different studies.

2. Writing documentation and specs for creating datasets.

3. Implemented and modified new and existing SAS Macros to generate Reports.

4. Prepared SAS datasets, Tables, Listings, Graphs, Reports and Summaries according to Standard Operating Procedures (SOPs),

protocols and Statistical Analysis Plan (SAP).

5. Performed time-to-event analysis, categorical data analysis, survival analysis (Kaplan-Meier Curves).

6. Formatted HTML, RTF and PDF reports, using SAS output delivery system ODS.

7. Generated various Listings, Tables and Summaries for Efficacy, Safety and Adverse Events of the Phase II and III clinical studies, using

procedures such as Freq, Means, Univariate, Summary, Tabulate, Report, Transpose, etc.

8. Conducted, documented and reported Data Validation inspection in compliance with FDA Regulations and other regulatory compliance.

9. Generated customized reports, listings, tables and graphs using various SAS Tools like SAS/Base, SAS/Graph, and Procedures such as

Sort, Means, Summary, Freq, Transpose, Print, Report etc.

10. Attended multi-disciplinary project team meetings, and actively participate and contribute to proceedings.

Environment: SAS 9.1.3 Base/Stat/Graph/Macro, RDBMS, oracle clinical, UNIX (Sun Solaris)

Sr. Statistical SAS Programmer --- Oct’05 –Apr’06

Nabi-Biopharmaceuticals

Rockville, MD.

Nabi Biopharmaceuticals engages in the development and commercialization of products in the areas of Gram-positive bacterial infections, hepatitis,

nephrology, and nicotine addiction.

Responsibilities:

1. Interacted with Biostatics team and documentation team for QC and FDA Guidelines.

2. Developed summarize clinical trials data using SAS/STAT procedures and data Step programming.

3. Integrated Clinical and Statistical reports, NDA summaries, ISS and ISE Documents, Annual reports.

4. Used many Base SAS procedures for analysis, management, presentation and access of the data.

5. Used SAS to analyze and process clinical trial data, to produce descriptive tables, data sets, listings, and graphs for different phases of

clinical trials.

6. Created SAS programs and macros to generate efficacy tables, graphs and listings in clinical study reports.

7. Developed and improved the efficiency of programs through the use of SAS macros.

8. Conducting data extraction, analysis, interpretation, and forecasting using BASE SAS and SAS PROCS.

9. Creating basic statistical and regression analyses using PROC MEANS, PROC SUMMARY, PROC UNIVARIATE, PROC TABULATE, PROC

REG.

10. Developing generalized utility macros to automate programs for standard reports and validations

11. Involved in Delivering Output using ODS (Output Delivery System) proc Template.

12. Making summary presentations of business highlights to senior management.

13. Design tables, graph for clinical study reports.

14. Extract data from Clintrial database using proc sql.

15. Involve in QC programs.

Environment: SAS9.3 SAS/GRAPH, Clintrial 4.3, oracle 8i, PL/SQL, Excel, PowerPoint, Windows NT, Citrix.

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Sr. SAS Clinical Programmer/Analyst -- March’05 - Sept'05

Human Genome Sciences, Inc

Rockville, MD.

Human Genome Sciences is a company with the mission to discover, develop, manufacture and market innovative drugs that serve patients with

unmet medical needs, with a primary focus on protein and antibody drugs.

Working on Phase 1 and Phase 2 trials on IMMUNOLOGY/INFECTIOUS DISEASE

and ONCOLOGY studies

Responsibilities:

1 As a Sr. programmer, I was part of a product team that included statisticians, clinical research assistants, data analysts and systems

analysts.

2 Written macro to automate the process like creating CRT datasets and automate documentation of output datasets. Created ISS/ISE

reports.

3 Developed programs for Listings, Summary tables and Patient profile as per study requirement

4 Designed tables, graphs for clinical study reports. Collected requirements from statisticians, prepare requirements document, follow up and

developed new macros as per statistician’s request. Involved in QC the programs.

5 Worked with DDE when reading external data files like Excel.

6 Extract data from Clintrial database using PROC SQL..

7 Creating Dose Escalation reports for each dosage.

8 Creating missing page reports and page status reports for each protocol.

9 Using proc compare creating monthly and audit reports.

Environment: SAS8.2, SAS/GRAPH, Clintrial 4.3, oracle 8i, PL/SQL, Excel, PowerPoint, Windows NT, UNIX (Sun Solaris)

Sr. Statistical SAS Programmer -- Jan’04 - Feb’2005

Pfizer Pharmaceuticals, PGRD

New London, CT.

DARE (Data Analysis and Reporting Environment) is the reporting component of GRADES (Global Reporting and Data Exchange). Prior to working in

DARE, the study team determines their reporting requirements and make choices within the Grades DCD (Data class definitions).These choices are

entered into DARE via study select. In this way, Dare is ready to accept project data from OC (or other) database, for reporting.

A data class: is a set of logically grouped data, also called domain e.g. Demography.

A data class Definition: is all of the defining documentation for specific data.

Development of SAS macros for Efficacy studies based on CDISC metadata model

Responsibilities:

1 As a Sr. programmer, I was part of a product team that included statisticians, clinical research assistants, data analysts and systems

analysts.

2 Written macro to automate the process like creating CRT datasets and automate documentation of output datasets. Created ISE/ISE reports.

3 Developed programs for Listings, Summary tables and Patient profile as per study requirement

4 Designed tables, graphs for clinical study reports. Collected requirements from statisticians, prepare requirements document, follow up and

develop new macros as per statistician’s request. Involved in QC the programs.

5 Worked with DDE when reading external data files like Excel.

6 Investigated and fixed several issues and proactively suggested new output formats to satisfy the statistician’s requirements. Developed

reports using SAS/ODS and PROC REPORT.

7 Writing Unix Shell scripting for automation jobs.

8 Used procedures like PROC FREQ, PROC MEANS, PROC SORT, and PROC PRINT, PROC REPORT. The generated reports are reviewed

and sent to the FDA (Food and Drug Administration).

9 Extract data from Oracle views.

10 Transform horizontal CRF data into CDISCS SDS Vertical Structure.

11 Prepare Test plans to validate developed SAS Macros.

12 Peer Review (QC) of SAS Macros coded by other member of the team.

13 Develop utility macros for QC of SAS codes. (e.g.: bail out when an assumption is not satisfied in a program or log has critical errors like

merge not followed by statement).

14 Worked for different studies like Ophthalmology, Daily pain Rating Scale(DPR),

15 Daily Sleep Interference Rating Scale (DSI). Nicotine Use (NU), Short Form 36, Smoking History (SMH).

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16 Creating data steps for preparing data for survival analysis for Proc lifetest, Proc Phreg, Proc Xstat, Proc Nparway.

Environment: UNIX, SAS 8.0 Base/Stat/Graph/Macro/Access/Connect, SAS/AF, SCL, RDBMS, oracle clinical

Sr. Statistical SAS Programmer/ -- Apr ‘02 - Dec ‘03

Bristol Myers Squibb, NJ

This application developed for Clinical Trials. Clinical Trials are conducted at each phase of a Drug’s development life cycle. These trials are conducted

to assess the efficacy and safety of treatment that is being studied. The methodologies under pinning these trials are "Randomization" means a

Treatment groups randomly to the Patients. Randomization, in principle, avoids selection and allocation biases. These types of studies are conducted

but not necessarily, at later phases of drug’s life cycle with some studies may run into several years. Depending upon a study design, subjects may

different treatments at different intervals of a study.

The following are the most commonly used study designs.

1 Cross-over

2 Parallel-Single randomization

3 Parallel-double randomization

Responsibilities

1 Extensively worked on Base SAS, using SAS Macros generation Randomized allocation, that is used to create a schedule, can be perform

variety of statistical algorithms PROCPLAN, POCOCK & SIMON algorithm, planned to implement in RAINMAN, generates randomized we

subjects.

2 Developed Oracle SQL scripts to extract data from warehouse to facilitate content validation.

3 Extensively used Proc Report, Proc Tabulate, Proc Univariate, and Proc Means.

4 Involved in documentation of design, Code and Reports for handling over the project.

5 Involved in delivering Output using ODS (Output Delivery System) proc Template.

6 Worked on creating SAS views from tables in oracle database using SAS/Proc SQL

7 Used base SAS procedures FREQ, TABULATE, and MEANS to validate current results with expected results.

8 Using SAS/SCL for application development.

9 Created reports in a form of text as well as Graphical using SAS/Graph, SAS/Reports and Base SAS procedures.

10 Writing Unix Shell scripting for automation jobs.

11 Using Proc Export, export all the datasets into MS Excel.

12 Using SAS/Access to communicate with Oracle database.

13 Using SAS macros generating tables and listing.

14 Validate all the tables and listing using validation rules.

15 Worked on Web logic server communication with SAS server using SAS/Connect API.

16 Worked with validation team to validate the applications compliance with 21 CFR part11 and other FDA mandatory regulations.

Environment : SAS v8.2, SAS v6.12,,SAS/AF,SAS/SCL, Oracle 8.x, SQL, PL/SQL,,JAVA1.22, NT, UNIX (Solaris 5.6)

Sr. Statistical SAS Programmer -- April’ 2001 - Mar ‘2002

ALZA Corporation CA

Involved in the implementation of Oracle Clinical system, Involved in maintenance and support of Oracle clinical system, associated database in

reporting environment, development of reports for users and post deployment support. They do IND (Investigating New Drug) regulations for most o

Followed the NDA, IND norms as laid study following NDA (New drug Approval) down by FDA. As a SAS consultant, involved with the Data Extrac

Data mining and Update & maintenance of the Data warehouse and Generation of various Sales and Marketing & Pharmaceutical data and Analysis

by extensive use of Base SAS, SAS/Macros, and SAS/Reports. This Package is for the manufacturing/production unit of the company, the end user b

sales and marketing department personnel.

Responsibilities

1 Worked with validation team to validate the applications compliance with 21 CFR part 11 and other FDA mandatory regulations

2 We are interacting with Biostatics team and documentation team for QC and FDA Guidelines.

3 Trained end-users and power users on the application.

4 Assisted the technical writing team and validation team

5 Prepared efficacy data for analysis using SAS, including data Validation.

6 Developed new SAS Macros to generate statistical tables and listings.

7 Developed summarize clinical trials data using SAS/STAT procedures and data Step programming.

8 Transferring data between SAS and Microsoft excel and access with Microsoft Visual Basic Script.

9 Excel Macro and VBA programming for data manipulation and presentation Quality Output.

10 Extensively used Proc Report, Proc Tabulate, PROC UNIVARIATE, and PROCMEAN.

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11 Documentation of Design, Code and Reports for handling over the project.

12 Involved in Delivering Output using ODS (Output Delivery System) proc Template.

13 Created SAS views from tables in oracle database using SAS/Access

14 Extensive experience in preparation of data mining, reports, writing scientific research papers, tables, listings and graphs.

15 Writing Unix Shell scripting for automation jobs.

Environment: SAS v8.2, SAS v6.12, oracle 8.x, Oracle clinical suite, SQL, PL/SQL, EXCEL, VBA, NT, UNIX (Solaris)

SAS Programmer/ Analyst -- Dec1999-Mar 2001

Healthcare Delivery Systems, AZ

Berlex is one of the Pharmaceutical clients of HDS, Developed an application for Berlex. The application deals with taking the transactions from p

server, processing them, creating orders, creating flat files and sending them to Berlex Laboratory. When Berlex ships the drugs, it sends back the

details and invoice details to HDS. The application also deals with Customer support screens and various reports used by the Program Mana

Department.

Responsibilities

1. Developed SAS programs for an automated business wide Incident Reporting and Customer Complaint system.

2. Worked on extracting data from the inventories using SQL Procedures.

3. Worked on validating the data with procedures like proc means, proc freq.

4. Developed Statistical and computing support for phase IV clinical studies involving respiratory and HIV compounds.

5. Excel market analysis for health care marketing firm to provide pre designed reports on projected and annual revenues. export data excel 4

spreadsheets

6. Experience on working Excel, PowerPoint to produce Adhoc reports for Users and Business partners for presentation of further analysis.

7. Generated statistical tables and listings to summarize clinical trial data using SAS/STAT procedures, SAS Macros, PROC REPORT.

8. Developed data step programming. Produced reports summarizing success rates and/or frequency counts using PROC REPORT.

9. Designed flowcharts indicating the input data sets and the techniques that would be used (sorting, merging, etc.) to get the desired output.

10. Developed SAS code according to the design. Preliminary data validation (clinical data quality checks) is done on the clinical trial data using SA

11. .Update JCL, submit jobs, download data, update Spreadsheets, update Marketing Switchboard release Reports, validate data, and create

ad-hoc reports in Support of weekly and monthly Market Performance Reporting.

12. Create detailed documentation of marketing analyst tasks performed in support of weekly and monthly Market Performance Reporting.

This documentation will be used to facilitate training and back-up for marketing analysts.

13. Extracting required data from IBM mainframe to local SAS Environment by SAS FTP and sync sort...

14. Extract data with PROC SQL’s pass through facility with ODBC connection to TERADATA and ORACLE warehouse.

Environment: SAS v6.2 (sas/base, SAS/SQL, sas/macros, sas/oracle clinical data), oracle, NT, Excel,

IBM Mainframe(VMS),JCL,TERADATA.

Programmer/ Analyst -- Jan 1998 -Nov 1999

Miracle Information Technologies, India

HP will be manufacturing the products like Monitors, FAX machines, Printers etc., it has customers all over the world in about thirty countries. The cu

hire the needed goods or lease them depending upon their requirement. All these transactions are done in their own currency. It maintains two Main

Systems ILS and MAG. All US info is stored in MAG and all the non-us info is stored in ILS. This system updates daily International info. The rep

maintained on all the transaction includes the manufacturing items, sales order processing.

Responsibilities:

1 Involved study and analysis of the guidelines given by Securities Exchange Board

2 Mapping the Data for creation of Universe.

3 Developed Full client reports.

4 Responsible for end user community training in basic and advanced reporting.

5 Developed JSP pages for interface between HTML and with Oracle 7i as Backend.

6 Developed BO repository creation in Oracle Database.

7 Created users, user groups, and securities, and granted access to the reporting module using the supervisor.

Environment: Business Object 4.1.2, (International Leasing System), MAG (Magellan), Java, Oracle7i, Crystal Reports, NT

Hindustan Machine Tools Ltd., India -- Mar 1997 – Dec 1997

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This software is developed on windows platform using client/server technology. This project contains 3 modules: Purchase, Receive, and Issue sectio

module activities are raising indents, enervating purchase orders, receiving goods from vendors and issuing goods to various departments. Each

provides various features like purchase orders, stock reports etc.

ROLE:

1 Developed Database using Oracle7.1.

2 Prepared Software Requirements Specifications and Design Documentation.

3 Maintained an on-line system for the information about the Consumer items and related order.

4 Generated reports like ordering file, Date of delivery, and quantity or items.

5 Prepared the information like Date-wise index, Item-wise index and Consumer name-wise index.

Environment : Oracle 7.1, Developer 2000, Crystal Reports

EDUCATION

BS in Engineering (Electrical& Electronics)

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