Data Sas Programmer

Mahidhar M [pic]

Mobile: 313-***-****

**********@*****.***

SUMMARY

Certified SAS programmer with an experience of six years in analysis,

design, development of Statistical data models including data extraction

and manipulation, writing macros and reporting on various projects, for

Pharmaceutical and Medical industries.

TECHNICAL PROFILE

. Six years of extensive experience in SAS systems that includes

SAS/BASE, SAS/MACRO, SAS/SQL, SAS/GRAPH, SAS/ODS, SAS/CONNECT,

SAS/ACCESS and SAS/STAT (V8.1 and V8.2 and V9.1.3) on Windows and UNIX

operating systems

. Skilled in SAS Programming, merging SAS Data Sets, Macro Facility,

Preparing Data, Producing Reports, Validating Reports, SAS Formats,

Storing and Managing Data in SAS Files

. Hands-on experience with SAS procedures like Proc Contents, Proc

Format, Proc Tabulate, Proc Transpose, Proc Sort, Proc Print, Proc

Freq, Proc Univariate

. Extensive experience in various Statistical Analysis using SAS/STAT

procedures such as PROC ANOVA, PROC GLM, PROC MIXED,PROC MEANS

. Experience in producing HTML, RTF and PDF formatted files using

SAS/ODS

. Developed and improved the efficiency of programs through the use of

SAS macros

. Proficient in SAS/BASE including Macros, SAS/SQL, SAS/STAT, SAS/GRAPH,

SAS/CONNECT and SAS/ACCESS

. Worked closely with statisticians and database management team to

analyze the clinical data, tables, listings, graphs and Ad-hoc reports

. Experience in producing external files and reports employing various

SAS procedures, like _null_, ODS, Proc Print, Proc Report, Proc

Summary, Proc Freq, Proc Mean, Proc Transpose, Proc SQL

. Extensive experience working in phases I, II, and III (ISS, ISE) of

clinical trials

. Extensive knowledge of the 21 CFR part 11 guidelines, CDISC and SDTM

of the FDA and data submission guidelines

. Ability to be successful in dynamic, small-team environments, and

partnering/collaborating with roles across the organization

. Excellent analytical, problem solving and communication skills,

leadership and management abilities

CERTIFICATIONS: Green Belt certificate in Six Sigma

SAS Certified BASE Programmer for SAS 9.

TECHNICAL PROFICIENCIES:

SAS Statistical Packages: SAS/BASE V8.2/V9.1, SAS/STAT, SAS/Macros,

SAS/ACCESS, SAS/GRAPH, SAS/SQL, SAS ENTERPRISE GUIDE, CDISC and SDTM

Operating Systems: Unix, Windows 95/98/2k/XP

Languages: SAS, SQL and C

Statistical tools: Minitab

Tools: Microsoft products - WORD, EXCEL, OUTLOOK and POWERPOINT (2003

and 2007)

PROFESSIONAL EXPERIENCE:

PAREXEL International, Durham,NC

Dec09- May10

Position: Sr.SAS Programmer

PAREXEL International is multi-national clinical research organization

which helps the

Pharmaceutical Companies in conducting the clinical trails. As a Sr. SAS

programmer I

was involved in the clinical trial studies conducted in Merck

Pharmaceuticals and

CSL-BEHRING.

Merck Project: Merck pharmaceutical company developing products in the

area of

Migraine and Hypertension. As a Sr.SAS Programmer I was involved in three

different

studies in the Phase I-III clinical trials data analysis.

Responsibilities:

. Involved in creating the SDTM and analysis datasets

. Generated tables and listings according to the mock shells provided by

statistician

. SAS Macros were used extensively in analysis of standard clinical data

and generated reports, graphs, listings, summaries and tables

. Used PROC SQL to perform queries, join tables, create and manage

tables, views, and indexes

. Generated the tables and Listings by using the standard rtf macro

. Performed validation on derived datasets, tables and listings adhering

to the standard operating procedures.

CSL-BEHRING project: CSL-Behring pharmaceutical company was developing

drugs for the Haemophilia A. As a Sr.SAS Programmer I was involved the

Phase-II clinical trials efficacy, safety and pharmacokinetics analysis of

the data.

Responsibilities:

. Created SAS data sets after extracting data from different sources

. Used different validation techniques such as proc means, proc freq,

and other data step techniques such as first. variable and last.

variable to validate the data.

. Conducted statistical analysis for the efficacy and the PK analysis as

per Statistical analysis plan and interpretation of results

. Developed the sas programs for the Pk analysis required for the study

as per the specifications given by the statistician of the generation

the tables, listings and graphs

Environment: SAS 9.1, SAS/BASE, SAS/SQL, SAS/MACROS, SAS/STAT, SAS/ODS,

SAS/GRAPH, UNIX, Windows XP.

BioNumerik pharmaceutical Inc, San Antonio, TX Aug

07- July 09

Position: SAS Programmer

BioNumerik pharmaceutical Inc is a company developing products in the area

of Oncology. It is conducting Phase I through Phase III clinical trials. As

a SAS analyst, my role was analysis of clinical trials data and generating

required reports, listings, summaries and graphs for submission to FDA and

other regulatory authorities.

Responsibilities:

. Involved in data management for clinical Phase I through Phase III for

data cleaning, formatting, creating tables an reports using SAS in

UNIX environment

. Involved in the analysis of the primary and secondary Endpoints of

the project

. Extracted data from CSV, Tab Delimited, Excel, ASCII, SAS Transport

Files

. Implemented data cleaning, formatting and pre-processing using Proc

Freq, PROC MEANS, PROC UNIVARIATE, PROC SQL

. Programmed Data listings and communicated any discrepancies in the

data to the Clinical Data Management. Involved in data integration and

table programming for Integrated Summaries of Efficacy and Safety

(ISS/ISE)

. Involved in writing mapping specifications for converting source data

into CDISC SDTM compliant data.

. Programmed Analysis variables and created Analysis datasets using

extracted datasets as source, according to Report Programming

Specifications provided by the Biostatistics department and was also

active in standardized delivery of ongoing reporting and metrics as

needed

. Gained an understanding of pertinent regulatory processes and forms

for Investigational New Drug applications [INDs] and New Drug

Applications [NDAs]

. Programmed Statistical Outputs in the form of Tables, Listings and

Figures using the Analysis datasets as source, according to Report

Programming Specifications provided by the Biostatisticians.

. Created Ad Hoc reports according to the requirements of Clients using

ODS, PROC REPORT and PROC TABULATE

. Created Outputs in the form of RTF, PDF, CSV and HTML files.

Environment: SAS 9.1, SAS/BASE, SAS/SQL, SAS/MACROS, SAS/STAT, SAS/ODS,

SAS/GRAPH, UNIX, Windows XP.

ELAN PHARMACEUTICALS South SF, CA: April

06- May 07

Position: SAS Programmer

Elan pharmaceutical is a leading company and which is involved in clinical

trials in the Neurological therapeutical area. I was involved in Phase I

and Phase II Clinical trials as a SAS Programmer. Created SAS data sets and

performed analysis using clinical data by extensive use of Base SAS,

SAS/Macros.

Responsibilities:

. Developed new SAS programs and modified existing SAS programs

. Created standard programs including macros

. Developed and implemented validation systems for statistical output

. SAS Macros were used extensively in analysis of standard clinical data

and generated reports, graphs, listings, summaries and tables

. Used PROC SQL to perform queries, join tables, create and manage

tables, views, and indexes

. Programmed edit checks to satisfy data collection, storage, and

analysis for clinical studies

. Merging, Indexing, appending and sorting the data sets Using PROC SORT

and various other SAS tools

. Performed Quality Assurance Procedure as per user's guidelines and

requests.

. Created electronic datasets (i.e. SAS transport files) for electronic

submission using PROC Copy as per 21 CFR parts 11

. Worked with Bio-statistician to analyze the results obtained from

various statistical procedures like PROC ANOVA, GLM, UNIVARIATE, MEANS

. Developed macros to generate customized report using DATA _NULL_ and

PROC REPORT, PROC TABULATE AND PROC SUMMARY

. Developed, maintain and utilize standard SAS naming conventions for

macro library supporting consistency and reusability of programs

. Participated in team meetings to discuss best programming practices.

Established and maintained sound working relationship and effective

communications within Biostatistics, Statistical Reporting, and the

Data Management group.

Environment: SAS/BASE, SAS/MACROS, SAS ENTERPRISEGUIDE 3.0, SAS/STAT,

SAS/GRAPH, SAS/SQL, UNIX AND WINDOWS 2000.

Daiichi Sankyo Inc, Parsippany, NJ Oct

05 - Mar 06

Position: SAS programmer

Daiichi Sankyo Inc is a pharmaceutical company focused on the development

of innovative products for the treatment of cardiovascular diseases. I was

involved in SAS Clinical trials as a SAS Programmer. Created SAS data sets

and performed analysis using clinical data.

Responsibilities:

. Case report forms were annotated

. Created SAS data sets after extracting data from different sources

. Prepared Analysis datasets and statistical data tables, listings using

SAS/BASE

. Developed efficient and readily modifiable SAS code using SAS/BASE and

SAS/MACRO FACILITY

. Used SAS/ACCESS to gather data from RDBMS like Oracle

. Reviewed study Protocol, Case Report Form (CRF) and performed

validation of Clinical trial data to identify illogical data entries

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

inclusion in Clinical study reports and regulatory submissions

. Evaluate data sources and data quality as needed

. Maintained, tested and debugged existing macros

. Created various ad-hoc reports as per the statistician's request

. Reviewed reports for consistency between listings and tables

. Performed quality review of SAS programs generated by other SAS

programmers and biostatisticians

Environment: SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, UNIX AND

WINDOWS 2000.

Veeda Clinical Research, India

Aug 04- Aug 05

Position: SAS Programmer

Veeda Clinical Research is a Clinical Research Organization specialized in

providing cost effective and rapid data management, statistics & medical

writing services for pharmaceutical companies.

Responsibilities:

. Created SAS datasets from different sources

. Done validation of listings and reports to check whether the data is

consistent and valid

. Created derived datasets as per specifications received from

statistician

. Analyze the data as per the guideline that are provided for the

analysis

. Writing edit checks for validating the clinical data using SQL

. Generation of Safety, efficacy and Ad-hoc tables and listings

. Drawing flowcharts indicating the input data sets, sorting and merging

techniques

. Contribute to clinical study design through review of protocols

. Monitor the progress of data flow from the investigator site to the

database

Environment: SAS/BASE, SAS/STAT, SAS/GRAPH, SAS/MACROS, MS-Excel, Windows

NT, SAS/SQL, SAS/ODS

EDUCATION:

Bachelors in Engineering, Osmania University, India

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