Data Sql

VISHNU V C

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

Summary

> SAS Programmer with over 6+ years of experience in Statistical

Analysis System (SAS) programming for developing and implementing

applications in pharmaceutical and clinical research.

> Extensive experience in Base SAS, SAS/MACROS, SAS/SQL, SAS/STAT,

SAS/GRAPH, SAS/CONNECT, SAS/ACCESS, SAS/ODS.

> Comprehensive skills in working with Base SAS, SAS/MACRO in UNIX and

Windows environments.

> Skilled in SAS Programming, Macro Facility, Preparing Data, PROCs,

Producing Reports, Validating Reports, SAS Formats, Storing and

Managing Data in SAS Files.

> Ability to follow CDISC data standards like ODM, SDTM, ADaM Standards.

> Experience in CDISC SDTM (3.1.1) in house conversions and thorough

understanding of Medra/Who Drug coding/decoding skills.

> Good Knowledge in Exporting Data to the FDA Submissions in Electronic

Format as well as eCTD Guidelines and other Regulatory Submissions

(NDA, including ISS and ISE).

> Experience and excellent command in producing reports employing

various SAS Procedures and handling large databases to perform complex

data manipulation using multiples files in SAS data steps.

> Proficient in clinical trials and preparing SAS datasets, Tables,

Listings, Graphs, Reports and Summaries according to requirements,

Statistical Analysis Plan.

> Extensive knowledge in data management like Merging, concatenating,

interleaving of SAS datasets.

> Experienced with PROC SQL, PROC TRANSPOSE, PROC GPLOT, PROC GCHART,

PROC DATASETS, PROC FORMAT, PROC COMPARE, PROC APPEND, PROC IMPORT,

PROC EXPORT, PROC TRANSPOSE, and PROC SUMMARY. SAS/STAT procedures

such as PROC CORR, PROC REG, PROC GLM, PROC CLUSTER, PROC ANOVA, PROC

LOGISTIC, PROC FREQ, PROC UNIVARIATE etc.

> Skilled in generating reports to communicate key findings and

articulate strategic implications using PROC PRINT, PROC REPORT, PROC

TABULATE, PROC MEAN, PROC GPLOT, and PROC GCHART.

> Good working knowledge of all kinds of Clinical Trials data like

Demographic data, Discrepancy data, Adverse Events (AE), Serious

Adverse Events (SAE), Laboratory data (Lab data), Physical and Vital

Signs and Audit trials as per Statistical Analysis Plan (SAP) and

expertise in all Phases of Clinical trials.

> Proficient in exporting generated outputs to other environments or the

web using various SAS method like create delimited, text files, ODBC.

> Generated output files in RTF, HTML, and PDF format using SAS ODS.

> Efficient in C/C++, UNIX, Shell Scripting and VB Scripting skills.

> Efficient in extracting data from Oracle and DB2 tables and loading

the data into DB2 tables.

> Experience in handling large volume data.

> Effective team player with excellent Communication & Interpersonal

skills and strong leadership qualities.

Technical Skills

Operating Systems: UNIX, WINDOWS 98/2000/XP, MS-DOS

Programming Languages: C, C++, SQL, PL/SQL, SQL Plus

SAS Tools: Enterprise Guide v4.1, SAS v9.1.3, v8.0, SAS

8/9.1, Base SAS, SAS/MACROS, SAS/STAT,

SAS/GRAPH, SAS/SQL, SAS/ACCESS, SAS/SQLe

Databases: Oracle 7.x/8, SQL server, DB2, MS-Access

98/2000, Oracle Clinical, ClinTrial

Professional Experience

Eli Lilly and Company

Indianapolis, IN

Clinical SAS Programmer Oct 2008 to

June 2010

Responsibilities:

. Imported data from Oracle database using SAS/SQL and after analysis

exported it into Excel

. Worked with statistician and clinical data manager to provide SAS

programming in analyzing the data, generating reports, TLG's as per

SAP.

. Performed Data analysis, statistical analysis, generated reports,

listings and graphs using SAS/Tools, SAS/Base, SAS/Macro, SAS/Graph,

SAS/STAT, SAS/SQL, SAS/Access

. Actively involved in designing annotated CRF with data management for

Phase II and III studies

. Actively involved in E-Submissions: SAS data transport (XPORT) files,

data definition document and statistical review in compliance with

CDISC standards

. Worked in Phase III and Phase IV.

. Created clinical data tables for Safety Analysis like Adverse Events

(AE), Lab tables, Vital Signs tables and generated reports using Proc

REPORT and DATA_NULL_ steps

. Applied procedures such as PROC SQL, PROC FREQ, PROC MEANS for data

analysis.

. Used Base SAS (MEANS, FREQ, TABULATE, REPORT etc) and SAS/STAT

procedures (REG, TTEST GLM, ANOVA, UNIVARIATE etc.) for summarization,

Cross-Tabulations and statistical analysis purposes. The generated

reports are reviewed and then sent to the FDA.

. Manipulated SAS Data sets. Techniques used include data merging,

frequency and Report, transpose, Summary, and Proc Means, and wrote

output to external files

. Created PL/SQL integration programs based on design specifications,

including Unit Testing

. Used sorting and merging techniques on the input data sets and used

Proc Transpose for Data manipulation, to get the required output using

SAS tools.

. Used procedures like Proc Transpose, Proc Univariate, Proc Compare,

Proc Gchart, Proc Gplot frequently and developed simple and reusable

Macros for standard report generation, analysis, validation to avoid

repetition in codes

. Used MACRO programming extensively to analyze data & created monthly

customized reports

. Used Output Delivery System (ODS) facility to create customized

reports directing SAS output to RTF, PDF and HTML files

. Mapping the developed datasets with DOMAIN Models of SDTM V3.1.1

standards before submissions.

. Implemented study specific procedures compliant with regulatory and

internal procedures and requirements.

Environment: Base SAS, SAS/MACRO, SAS/ACCESS, SAS/SQL, SAS/GRAPH, SAS/STAT,

SAS/MACRO, ClinAccess, ClinTrial, MS Excel, Windows XP.

Clinovo

Sunnyvale, CA

Clinical SAS Programmer

Sep 2007 to Sep 2008

Responsibilities:

. Extracting Clinical data from the database (Oracle and DB2) using

SAS/Access, SAS SQL, SAS/Connect, Procedure and create SAS permanent

data sets in SAS library.

. Extensively involved in Oracle PL/SQL programming to create Triggers,

Database Packages.

. Programming of data listings, Summary tables, Categorical tables and

figures using Base/SAS, SAS/GRAPH, SAS/MACROS..

. Analyzed data using SAS/Stat procedures

. Performed Data validation using SAS according to data handling rules

mentioned in Statistical Analysis Plan (SAP)

. 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 (21 CFR)

Part 11,FDA.

. Created SDTM domain datasets from raw datasets as per the

specifications.

. Transformed raw data in to CDISC (SDTM) standards by mapping, created

analysis ready ADaM datasets along with Define. PDF

. Used PROC IMPORT and PROC EXPORT to transfer data into different

formats.

. Used data cleaning techniques such as Proc freq, Proc Print, _null_,

proc means, proc tabulate, Proc Univariate, Proc SQL, nodupkey, Proc

character, invalid, and discrete data character values.

. Extensively used SAS procedures including Proc life test and generated

Kaplan-Meier curves to estimate the survival probability of cancer

patients for different treatments.

. Involved in the generation of integrated safety summary (ISS) and

integrated efficacy summary (IES) reports for onward submission to

FDA.

. Created RTF, PDF, and HTML listings, tables and Reports using SAS/ODS

. Involved in creating ODM XML files as per the CDISC standards for

electronic submissions to the FDA.

Environment: SAS/BASE, SAS/GRAPH, SAS/ACCESS, SAS/MACROS, SAS/SQL, SAS/ODS

Windows

MAP Pharmaceuticals, Inc.

Mountain View, CA

Clinical SAS Programmer

Aug 2006 to Aug 2007

Responsibilities:

. Created SAS datasets by taking database tables as input datasets using

SAS/ACCESS SQL Pass Through Facility

. Wrote Edit Check Programs for data validation before using for final

analysis.

. Provided SAS Programming and Statistical support to clinical studies.

. Developed analysis models using Survival Models, Linear and Non-linear

Models, Experimental (SAS/STAT).

. Performed validation of the derived variables, reports, and listings.

. Involved in Mapping Raw datasets to SDTM Datasets as per CDISC

standards.

. Created Analysis datasets according to the specifications provided by

CDISC standards

. Worked on ISS and ISE reports for NDA submission to FDA

. Analyzed reference and the test responses using PROC FREQ using

Fisher's exact test option.

. Analyzed data from the lab reports and vital signs using PROC GLM

procedures.

. Manipulate and integrate large data sets from multiple sources using a

variety of software applications including: SAS, SAS access to Oracle,

SQL, PL/SQL, Teradata, Micro Strategy, MS Access.

. Analyzed descriptive statistics and demographic data using procedures

like FREQ, MEANS, TABULATE, UNIVARIATE, SUMMARY, CORR, REG.

0. Created Tables and Listings for Clinical Study Reports (CSR).

1. Created graphs by using the SAS annotate facility, and SAS procedures

like Proc GChart and Proc GPlot.

. Developed statistical reports using various procedures such as

LOGISTIC, GLM, ANOVA, and LIFETEST

2. Experience in CDISC standards and different models like Analysis

Dataset Model (ADAM) Operational Data Model (ODM) and Study Data

Tabulation Model (SDTM)

3. Created ODM XML files according to CDISC standards for submission to

FDA

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

Windows XP .

Gentiae Clinical Research

San Bruno, CA

Clinical SAS Programmer

Feb 2004 to Feb 2006

Gentiae Clinical Research, Inc. is a Contract Research Organization (CRO)

that provides cardiovascular core laboratory services to pharmaceutical,

biotechnology, and medical device companies. The company offers cardiac

safety monitoring, data management, and global logistic services to support

clinical trials in various phases of development. Additionally, it offers

statistical desinging, data analysis, and advisory services. GCR uses

LifeSignals technology platform, an integrated suite of technology and

clinical services for digital acquisition, centralized analysis, and

enterprise-wide management. Gentiae Clinical Research, Inc. was founded in

2001 and is headquartered in San Bruno, California with an additional

office in Cologne, Germany.

Responsibilities:

0. Created and extracted Clinical data tables from Oracle Clinical and to

SAS using SAS tools like SAS/ACCESS, LIBNAME engine.

1. Performed Data cleaning and Data validation by Edit check programming

2. Made extensive use of PROC IMPORT, IMPORT Wizard, SAS/ACCESS to Pc

files for importing external files of MS EXCEL and ACCESS

format.

Documented the mapping specification rules and created a specification

document.

4. Developed routine SAS macros to create tables and listings for

inclusion in Clinical study Report (CSR) and regulatory submissions

and maintained the existing ones.

5. Created customized reports by using Proc TABULATE, Proc REPORT, and

Proc SUMMARY and also provided descriptive statistics using Proc

MEANS, Proc FREQ, and Proc UNIVARIATE

6. Generated various graphs using SAS/GRAPH including Kaplan-Meier

curves, bar charts, and scatter plots.

Wrote procedure using PL/SQL for integrity check and constraints

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

electronic submissions to the FDA.

9. Generated output files in HTML, RTF & PDF formats using SAS/ODS

Environment: SAS/BASE, SAS/ACCESS, SAS/GRAPH, SAS/SQL, SAS/MACROS, SAS/ODS,

Windows, SQL, UNIX

Vimta Labs

Hyderabad, India

SAS Programmer Jul

2002 to Jan 2004

Responsibilities:

. Created SAS datasets from Oracle database with random sampling

technique and created Oracle tables from SAS datasets by using SAS

Macros

. Created large datasets by combining individual datasets using various

inner and outer joins in SAS/SQL and dataset merging techniques of

SAS/BASE

. Analyzed data using various statistical PROCEDURES like PROC SUMMARY,

PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC REG and PROC ANOVA

. Used SAS/Macro facility to create macros for statistical analysis,

reporting results and data extraction

. Proposed a set of action plans to mitigate the risks identified with

the sourcing decision

. Generated HTML, Listings, EXCEL and RTF reports for presenting

findings of various statistical PROCEDURES using PROCEDURES like PROC

REPORT, PROC PRINT, PROC FREQ and also SAS ODS

Environment: SAS 6.0 (BASE, STAT, GRAPH, MACRO, ETS and ODS), Oracle 8.0,

PL/SQL

EDUCATION

Bachelor of Computer Science, Anna University, Chennai, India

Contact this candidate