Data Quality Assurance

Resume of Padma Kishan

Ph: 318-***-****

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

SUMMARY:

Certified Programmer for SAS 9 with seven years of professional experience in SAS programming

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with emphasis in clinical data management, data cleaning, data mining, data validation and

statistical report generation.

Thorough knowledge of device release process from initial submission in Clinical Trial Phases (I-

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IV) including developing annotated Case Report Forms (CRFs), Data Definition Table (DDT)

and preparation of Case Report Tabulations (CRT) in compliance with Clinical Data

Interchange Standards Consortium (CDISC) standards.

Working knowledge of CDISC v3.1 including models Study Data Tabulation Model (SDTM),

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Analysis Dataset Model (ADaM) and XML based Operational Data Model (ODM).

Thorough knowledge of generating Integrated Summary of Safety (ISS) and Integrated

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Summary of Efficacy (ISE) for FDA submission.

Thorough knowledge of design and modification of Clinical Datasets, Statistical Reports and Graphs

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according to guidelines lay down in Statistical Analysis Plan (SAP), Standard Operating

Procedures (SOP) and Data Specs.

Experience with categorizing clinical data for Intervention, Finding and Event Classes from Patient

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Disposition, Exposure Time, Adverse Event, Concomitant Medication and Laboratory Data

domains.

Commendable experience with generation of Reports, Tables, Listings and Graphs (TLGs) using

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Proc Report, Proc Tabulate, Proc Univariate, Proc Means, Proc Gplot, Proc Gchart etc and

DATA _NULL_.

Working experience with Oracle Clinical and ClinTrial databases including developing Data

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Collection Instruments (DCIs) and Data Collection Modules (DCMs), designing Discrete Value

Groups (DVG) and Univariate Checks.

Hands on experience in interacting with data from various file formats like Excel, ASCII, CSV,

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Access, RTF, HTML, XML and PDF using Proc Import/Proc Export, SAS Enterprise guide,

SAS/ACCESS and SAS/ODS.

Experience with using SQL PASS THROUGH FACILITY and LIBNAME statement to interact

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with databases.

Experience with using Macro Facility in the generation of Statistical Reports, Ad-hoc reports and

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Data Cleaning.

Working knowledge of performing Data Analysis using SAS programming techniques in

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compliance with 21 CFR Part 11.

Experience with preparing documents required for Investigational New Drug (IND) and New Drug

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Application (NDA) submissions.

Experience with developing Quality Control (QC) and Quality Assurance (QA) techniques on

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work performed by others.

Thorough understanding of Software Development Life Cycle (SDLC).

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Knowledge of programming languages such as C and MATLAB.

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Good analytical, problem solving, communication and interpersonal skills.

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TECHNICAL SKILLS:

SAS 8.2/9.1.3,SAS/GRAPH,SAS/STAT,SAS/CONNECT,

• SAS Tools:

SAS/ACCESS, SAS MACROS, SAS ODS

• Data base Packages: Oracle 7/8, SQL, Oracle Clinical, 4.0, MS Access 98/2000

• Operating Systems: Windows XP / 2000 / NT / 98, UNIX

MS Office 97/2000/2007.

• Office tools:

Professional Experience

Merck, PA Apr 08- Present

SAS Programmer

Merck & Co., Inc. is a global research-driven pharmaceutical company. Merck discovers, develops,

manufactures and markets vaccines and medicines to address unmet medical needs.

Responsibilities:

• Analyzed the clinical trial data for phases (I-IV) for Oncology study

• Generated CRTs, TLGs, Integrated Summary of Safety (ISS) and Integrated Summary of

Efficacy (ISE) as per SOP and SAP documents.

• Performed Mapping of datasets created to be in compliance with SDTM and ADaM standards.

• Generated define.xml as a part of CRT for FDA submission.

• Developed efficient, well documented, readily comprehensible, modifiable and reusable SAS

programs using Base SAS and SAS Macros.

• Extracted database files using SQL Pass Through Facility and LIBNAME statements.

• Performed Data Cleaning, Data Validation and Data Documentation on the work developed by

other programmers.

• Created ad-hoc reports as per the requirements.

• Generated SAS GRAPHS using Proc Gplot and Proc Gchart and Goptions and Gdevice

functionalities.

• Generated descriptive and categorical statistical analysis using Proc Means, Proc Univariate, Proc

Npar1way, Proc Anova and Proc Glm.

• Calculated p-values using different statistical analysis such as Cochran-Mantel-Haenszel and

Wilcoxon signed rank test using Proc Freq and Proc Lifetest respectively.

• Used Proc Import/Proc Export, SAS/ODS and SAS Enterprise guide to generate datasets from

external file formats (ASCII, Excel, CSV, Access and PDF) and to convert created datasets into

external file formats.

• Performed data manipulation including sorting, merging, concatenating and printing data using

PROC SORT, PROC MERGE and PROC PRINT respectively.

• Performed QC and QA on the work developed by others.

Environment: SAS 8.2, SAS/BASE, SAS/MACROS, SAS/STAT, SAS/ODS, SAS/ACCESS,

SAS/GRAPH, WINDOWS.

Covance, NJ Dec 06- Mar 08

SAS Developer

Covance (CRO) is one of the world’s largest and most comprehensive drug development services

companies, helping pharmaceutical and biotech companies of all sizes fulfill their research and

development, clinical trial, regulatory and marketing-support needs.

Responsibilities:

• Analyzed clinical trial data through Phases (I- III) in Cardiology therapeutic area.

• Performed data mapping to generate datasets in compliance with SDTM standards.

• Used company defined macros extensively to standardize programs and make the code

reusable.

• Developed, modified and employed macros for generating weekly and monthly reports and ad-hoc

reports.

• Developed edit Check Programs and Data Validation programs to avoid entering of erroneous data.

• Provided customized reports using DATA _NULL_.

• Converted data from normalized form to non- normalized form and vice-versa using Proc

Transpose and arrays.

• Imported ORACLE data tables into SAS data files using SQL Pass through Facility, and uploaded

SAS data files into ORACLE tables using Proc Dbload.

• Generated Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) in

accordance with data spec regulations.

• Developed Case Report Tabulations (CRT), TLGs and Analysis datasets in compliance with

Study Data tabulation Models (SDTM) and Analysis Dataset Models (ADaM) respectively.

• Conducted basic and advanced regression analysis and multivariate test using Proc Logistic, Proc

Glm and Proc Reg.

• Produced statistical calculations using Proc Freq, Proc Univariate and Proc Summary.

• Performed QC and QA on the work performed by others.

• Performed Data Cleaning and Data validation using SAS Procedures like Proc Means, Proc

Univariate and proc Format.

• Used Proc Lifetest to calculate non parametric estimate of survival distribution function over time.

Environment: SAS 8/8.2, SAS/BASE, SAS/ODS, SAS/MACROS, SAS/GRAPH, SAS/SQL,

SAS/STAT, WINDOWS.

Premier Research Group, MA Jan 05- Nov 06

Statistical Programmer

Premier Research Group is a Contract Research Organization (CRO). It provides clinical trial

management and information services to the pharmaceutical and biotechnology industries all

over the world.

Responsibilities:

• Produced quality customized reports by using Proc Report, Proc Tabulate, Proc Freq, Proc

Univariate, Proc Format and Proc Summary

• Used UNIX Shell scripting to FTP data from different servers.

• Created Unix Shell scripts and FTP to access the transport file across the network.

• Formatted HTML, XML, ASCII, CSV, EXCEL, PDF and RTF reports, using SAS - Output

Delivery System (ODS).

• Generated customized reports using DATA _NULL_.

• Involved in developing Tables and listing for statistical analysis.

• Worked with Med-DRA coded clinical data for creating adverse event data sets.

• Produced descriptive and categorical statistics using Proc Means, Proc Summary, proc Freq and

Proc Univariate

• Used Proc Lifetest to calculate non parametric estimate of survival distribution function over time

using Kaplan Meier estimates.

Employed Proc Phreg and Proc Logistic to perform Conditional Logistic Regression (CLR)

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analysis.

Environment: SAS 8.2, SAS/STAT, SAS/SQL, SAS/BASE, SAS/CONNECT, SAS/ACCESS,

SAS/GRAPH, Excel/Access 2000 and UNIX.

Access Pharmaceuticals Inc., TX Apr 03- Dec 04

Clinical SAS Programmer

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that focuses on adding value

to exciting product concepts in research by advancing those products through clinical development. The

company’s primary focus is in oncology and supportive care of cancer patients, although studies in

dermatology field are carried as well.

Responsibilities:

• Produced Tables, Listings and Graphs for Clinical Study Reports in compliance with 21 Code of

Federal Regulations (21CFR) Part 11.

• Developed patient profiles with safety and efficacy information for clinicians review.

• Developed SDTM and ADaM compliant datasets using Specifications provided.

• Wrote Edit Check Programs for data validation before using for final analysis and created CRT

(Case Report Tabulations) for FDA submission.

• Produced output in various formatted files such as Excel, Access, RTF, PDF and HTML using SAS

ODS.

• Worked in Phase III and IV of clinical trials and also presented results in the standard CDISC

formats.

• Used SAS/SQL to perform merging, interleaving and concatenating of multiple datasets.

• Used SYMPUT and INTO: functions to create macros in DATA and PROC SQL respectively.

• Interacted with other databases using SQL PASS THROUGH FACILITY.

• Performed data integrity checks and data cleaning using SAS Macros and data step.

• Provided statistical and output manipulation techniques using Procedures like Proc Means, Proc

Sort, Proc Print, Proc Freq, Proc Univariate, Proc Anova and Proc Corr, Proc Npar1way.

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

CDISC, WINDOWS.

Medwin Hospitals, INDIA Mar 02- Feb 03

Clinical Programmer

Medwin Hospitals, a Multi Specialty Hospital with excellence in modern health care is a major player in

scripting the medical landscape of the Indian nation. The group has continuously been at the helm of

several game-changing innovations in Indian healthcare industry.

Responsibilities:

• Involved in analysis of data from Phase (I- IV) in cardiology and Central Neural System (CNS)

therapeutic field.

• Performed data entry, conversion, validation, upload and download of the patient data to and

from a PC respectively.

• Performed data analysis, statistical analysis generated reports and TLGs using SAS/BASE,

SAS/STAT, SAS/MACROS and SAS/GRAPH.

Maintained patient Demographic data, Adverse event data and Investigational drug log data and

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further analyzed them to generate tables, listings and reports.

• Produced quality customized reports by using Data _Null_, Proc Tabulate, Proc Univariate, Proc

Report, Proc Summary and Proc Sql.

• Performed documentation of the coded programs for future reference.

• Used macro facility to generate weekly and monthly reports.

• Involved in calculating and analyzing the p-values and CI limit for drug analysis.

• Provided statistical support to Statisticians and Biostatisticians.

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

EDUCATIONAL QUALIFICATIONS:

Master of Science,

Louisiana Tech University, LA, USA.

Bachelor of Technology in Bio-Medical

Jawaharlal Nehru Technological University (JNTU), Hyderabad, India.

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