Data Clinical

CHANDRA ®732-***-****

SUMMARY

Over * years of experience in software development, design, analysis, coding, implementation,

maintenance and support as a SAS Programmer/Analyst with profound experience in

Pharmaceutical and Clinical industries.

• Strong experience of SAS Base, SAS Macros, SAS SQL, SAS Stat, SAS Graph, SAS

Access, SAS ODS.

• Excellent knowledge and experience in creating analysis clinical trials datasets like

demographic data, Adverse Events (AE), laboratory data, Vital Signs and other complex

elements

• Experience in implementing CDISC SDTM for intervention, event and findings domain

models and ADaM standards for TTE dataset etc, knowledge of SDTM terminologies

• Experienced in working closely with statisticians to provide SAS programming in

analyzing clinical trials data and generating Statistical Analysis Files, Tables, Listings,

Summaries, and Graphs

• Strong knowledge of Statistical Analysis Plan, Standard Operating Procedures,

Protocols of clinical trials.

• Skilled in writing automated SAS tasks and conversion of SAS Datasets to various file

types (including HTML, Excel, PDF, Word) as well as converting various file types to SAS

Datasets.

• Proven skills in Data Cleansing, Data Archival, and Data Migration utilizing SAS on UNIX,

Windows and Mainframes environments.

• Extensive experience in developing standard and Ad hoc Reports, tables, listings and

graphs.

• Strong experience in SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH,

SAS/ACCESS, SAS/ODS, SAS/SQL,

• Proficient in different SAS procedures like PROC PRINT, REPORT, SUMMARY, FREQ,

TABULATE, MEANS, UNIVARIATE, TRANSPOSE, and Data_NULL_

• Modified existing SAS programs and created new programs from scratch using SAS

MACROS to improve ease and speed of modification as well as consistency of results.

• Experience in using SAS to read, write, import and export to another data file formats,

including delimited files, Spreadsheets, Microsoft Excel and Oracle databases

• Extensive experience and proficiency in using SAS/ODS to create output files in a variety

of formats including RTF, HTML and PDF;

• Exceptional problem solving skills for delivering useful and prudent solution.

EDUCATION & CERTIFICATION

Post Graduation in Computer Applications

Bachelor of Engineering from Andhra University, India.

TECHNICAL SKILLS

SAS Programming: SAS/BASE, SAS/MACROS, SAS/SQL, SAS/ODS, SAS/STAT,

SAS/ACCESS, SAS/CONNECT and SAS/GRAPH.

Databases: ORACLE 8i/9i/10g, MS ACCESS, MSSQL

Languages: C, JAVA, SQL and PL/SQL

MS Tools: MS Excel, MS Word, MS PowerPoint, MS Access

Operating Systems: WINDOWS 98/XP, UNIX (Sun 9)

Tools: Putty, Toad, Enterprise Guide.

PROFESSIONAL EXPERIENCE

WORK EXPERIENCE

ALPHARMA/KING PHARMA, PISCATAWAY, NJ

Dec’08--Present

Role: Clinical Statistical Programmer.

Description: Alpharma is a specialty pharmacy company with an established leadership in Pain

Management. This project has to evaluate the efficacy of Diractin® in patients with mild to

moderate pain related to osteoarthritis (OA) of the knee. And to evaluate the overall safety of

Diractin® in patients with mild to moderate pain related to OA of the knee.

Successfully designed and implemented statistical reporting processes for regular data collection

and clinical data analysis. Generated Safety tables, which also involved in analyzing data and

generating Reports.

Responsibilities:

• Worked on creating Analysis datasets referring to the specifications provided according

to the CDISC standards.

• Before writing SDTM code, documented mapping specification rules and create a

mapping specification document with mapping variables in Excel sheet.

• Develop SDTM data mapping and create SDTM datasets per CDISC standard for FDA.

• Design and develop Statistical analysis data set ADaM in CDISC standard.

• Create define.pdf for SDTM and define.pdf for ADaM.

• Transforming the Data and creating Analysis data sets by defining additional variables,

concatenation of data sets, merging different data sets using Sql joins and Data step

programming.

• Used statistical procedures like (Univariate, Freq, Report, SQL, Transpose, and data

_null_) to generate tables, listings and P-values.

• Used SAS procedures to create analysis programs and compare the results with Table

Results in production.

• Collaborated with Biostatisticians and representatives from clinical to regulatory to

develop clinical trial reporting systems, tables, patient listings/graphs, case report form

tabulations, and derived datasets.

• Created complex and reusable Macros and extensively used existing macros and

developed SAS Programs for Data Cleaning, Validation, Analysis and Report generation and

tested and debugged existing macros.

• Extensive experience in Clinical Data Management; performing edit checks and data

coding using MedDRA and WHODRUG.

• Developed SAS Integrated Efficacy and Integrated Safety (ISS/ISE) analysis reports for

NDA submission as per FDA regulations and company standards.

• Used Output Delivery System (ODS) facility to write custom safety and efficacy reports

directing SAS output to RTF and HTML files.

• Applied interleaving, one-to-one, concatenating, merging, and appending techniques to

SAS datasets while combining them.

• Carried out all activities in accordance with SOP’s working within the framework of the

Quality Management system to Good Clinical Practices (GCP’s).

• Create documents and sops with coding standards, algorithms and data issues for future

references.

Environment: SAS/BASE 9.1.3, SAS/MACRO, SAS/ACCESS, SAS/GRAPH, SAS/STAT,

SAS/SQL, SAS/ODS, CDISC3.1.2, ORACLE and Windows XP, UNIX.

COVANCE, GAITHERSBURG, MD

Feb’08 – Dec’08

Role: Clinical Statistical Programmer.

Description: Covance is Global CRO Company which develops design and conducts studies, as

well as analyzes and publishes findings on clinical studies for Pfizer Inc. The study was a

multinational, cross-sectional, observational study of subject self-reported functional health, well-

being, HRU, economic burden, and disease burden among subjects with FMS ( Fibromyalgia

Syndrome). The study was conducted in France and Germany. This non-interventional study

involves administering a one-time survey and is independent of any medication that the patient

receives. The analysis will largely be descriptive, reporting summary statistics for the BPI, MOS,

FIQ, HADS, and the EQ-5D scores, and, where possible, comparing findings to published norms

or data For each country and overall. Summary statistics of key variables, such as age and pain

scores, and frequency distributions of medications and health resource utilization outcomes, will

be reported.

Responsibilities:

• Worked on creating Study data Tabulation models (SDTM) and Analysis datasets (AD)

referring to the specifications provided according to the CDISC standards.

• Before writing SDTM code, documented mapping specifications rules and create a

mapping specification document with mapping variables in Excel sheet.

• Transforming the Data and creating Analysis data sets by defining additional variables,

concatenation of data sets, merging different data sets using Sql joins and Data step

programming.

• Assist in the design of statistical plans and case report forms for clinical studies.

• Used statistical procedures like (Univariate, Freq, Report, SQL, Transpose, and data

_null_) to generate tables, listings and P-values.

• Used SAS procedures to create analysis programs and compare the results with Table

Results in production.

• Summary statistics for the BPI, MOS, FIQ, HADS, and the EQ-5D scores were calculated

by statistical procedures like Univariate, Freq, and means.

• Using standard bi-variate methods, such as correlation coefficients, chi-square test,

Fisher’s exact test, and one-way analysis of variance (ANOVA) models to find Relationships

between patient- and physician-reported outcomes.

• Used Macros to generate ODS to .RTF in table production code and reporting summary

statistics for the BPI, MOS, FIQ, HADS, and the EQ-5D scores.

• Ensure the validation and quality assurance of output.

• Responsible for the proper coding, documentation and validation of SAS

programs/macros/procedures to produce the standardized data display.

• Establish standardized data displays and standard edit checks to support clinical trial

integrated reports using SAS.

• Establish and maintain libraries of fully documented and validated applications

programs / macros / procedures which are used and recycled.

• Develop tools and techniques for improving clinical trials data process efficiencies that

includes data management listing support, data validation, analysis database programming,

statistical table/listing/figure generation and validation.

• Review CRF's and data listings to ensure that all captured data follow the rules outlined

by the protocol and analysis plan.

• Collaborate with project teams to complete scientific reports and review reports to ensure

accuracy and clarity.

• PROC SQL was used in coding concomitant medications data with WHODRUG and

medical history data was coded based on MedDRA.

• Formatted RTF reports, using SAS - output delivery system ODS. Documented and send

designed SAS code, Reports to the Client.

• Created Output reports, production table code and analysis results in .bat files and export

to the client environment for reviewing.

• Carried out all activities in accordance with SOP’s working within the framework of the

Quality Management system to Good Clinical Practices (GCP’s).

• Create documents and sops with coding standards, algorithms for future references and

create documents to inform the data issues to data management team.

Environment: SAS/BASE 9.1.3, SAS/MACRO, SAS/ACCESS, SAS/GRAPH, SAS/STAT,

SAS/SQL, SAS/ODS, CDISC 3.1.1, and Windows XP, UNIX.

Takeda, Deerfield, IL

Jan’07 – Feb’08

Role: Clinical Statistical Programmer.

Description: Takeda is a Global Research pharmaceuticals company which develops targeted

medicines for Type 2 Diabetes, and Evaluate the Relative Bioavailability for Type 2 Diabetes and

Involved in Phase 1, Phase 2 and Phase 3 studies. The study was Phase-1-III trial to evaluate

whether Phiagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who

are not sufficiently controlled with diet and exercise.

Responsibilities:

• Working on Phases I, II & III of Clinical Trials and performed Clinical Data Analysis

and generated SAS Datasets.

• Extensively involved in the process of data validation, where tables and listings

produced by a CRO were analyzed and corrected.

• Created clinical data tables like demography summary tables like, Adverse Effects

(AE), Serious Adverse Effects (SAE), Quality of Life (QOL) tables.

• Generated customized report using various SAS procedures such as PROC

TABULATE, PROC REPORT and DATA _NULL_.

• Extensively dealt with Proc Report, Tabulate, Sort, Contents, Freq, Univariate,

Means and also used Proc compare, append, copy along with some SAS/STAT procedures.

• Designed and created SAS datasets from various sources like Excel datasheets, flat

files, statistical analysis files, tables, listings, and graphs for all phases of clinical drug trials

studies. Create study specific SDB and Create study specific derived dataset specifications.

• Create a verification plan with the Project Statistician and validate the tables agreed

upon with the Statistician and create a Verification report.

• Any discrepancies with the original program were analyzed and discussed with the

statistician to make the appropriate changes in the specs provided.

• Wrote QC programs to validate the Sas code written by other and validate the

outputs.

• Performed Data Cleaning and Check programs for data validation before using for

the final analysis.

• Transforming the Data and creating Analysis data sets by defining additional

variables, concatenation of data sets, merging different data sets using Sql joins and Data

step programming.

• Produced output in various formatted files such as Excel sheets, RTF, PD F and

HTML using SAS/ODS techniques.

• Extensive experience in Clinical Data Management; performing edit checks and data

coding using MedDRA and WHODRUG.

• Developed Integrated Efficacy and Integrated Safety (ISS/ISE) analysis reports

across multiple studies.

• Before writing SDTM code, documented mapping specification rules and create a

mapping specification document with mapping variables in Excel sheet.

• Develop SDTM data mapping and create SDTM datasets per CDISC standard for

FDA.

• Experience in CDISC standards and different models like Analysis Dataset Model

(ADAM) Operational Data Model (ODM) and Study Data Tabulation Model (SDTM).

• Develop SDTM data sets and to map raw data into standard data model.

• Carried out all activities in accordance with SOP’s working within the framework of

the Quality Management system to Good Clinical Practices (GCP’s).

• Developed and used SAS Macros programs to generate reports, tables and listings

for clinical and bio-statistical review.

• Generated reports and summaries for FDA submissions and Experience in

submitting ISS and ISE documents to FDA.

• Validate the define. PDF documents and it contents before submitting the FDA.

Environment: SAS/BASE 9.1.3, SAS/MACRO, SAS/ACCESS, SAS/GRAPH, SAS/STAT,

SAS/SQL, SAS/ODS, CDISC3.1.1, ORACLE and Windows XP, UNIX.

Eli Lilly & Company, IN

Jan’06 – Jan’07

Role: Clinical Statistical Analyst

Description: Eli Lilly is a leading global biopharmaceutical company dedicated to the research,

development and commercialization of innovative pharmaceutical and biotechnology products in

the fields of central nervous system disorders(CNS) allergy/respiratory diseases, immune and

inflammatory disorders and oncology Involved in Phase 1, Phase 2 and Phase 3 studies and a

regulatory submission.

Responsibilities:

Load/Access Systems are built for clinical studies to aggregate data from acquisition systems into

one database. The final output of the Load System is a SAS database that stores and shares

clinical trial data for the submission and the support of clinical studies. The Load Systems

produce a structured data storage environment that provides accurate and efficient analytical

data support for clinical studies.

• Created, modified and reviewed SAS macros using Base SAS and SAS/macro for

aggregation and cleaning of clinical trial data.

• Supported clinical trials interim and final data locks for Phase 3 clinical trials.

• Wrote code using SAS/Base and SAS/Macros to extract clean and validate data from

Excel files, Access Database, and Oracle database server.

• Data transmission and integrity check of the SAS datasets.

• Performed Data analysis, statistical analysis, generated reports, listings and graphs using

SAS/Base, SAS/Macro and SAS/Graph, SAS/SQL, SAS/Access.

• Produced quality customized reports by using TABULATE, REPORT, and SUMMARY

and also provided descriptive statistics using MEANS, FREQ.

• Wrote QC programs to validate the Sas code written by other and validate the outputs.

• Developed SAS macros for data cleaning and Reporting and to support routing

processing.

• Developed and maintained general-purpose and ad hoc SAS programs/Macros for the

validation, Extraction, Presentation, manipulation, analysis, and reporting

• Integrated SAS datasets into Excel using Direct Data Exchange, using SAS to analyze

data, statistical tables, listings and graphs for reports

• Export and import an XML document data in CDISC ODM format based on SDTM

standards by the PROC CDISC Procedure.

• Formatted HTML and RTF reports, using SAS - output delivery system ODS.

Documented and designed SAS code and Reports

• Transferred and migrated data from one platform to another to be used for further

analysis. Extracted data from Oracle ODBC and SQL pass through facility or LIBNAME

method and generated ad-hoc reports.

Environment: BASE SAS, SAS/ MACRO, SAS/ SQL, SAS/ STAT, SAS/CONNECT and

SAS/ACCESS, SAS/ENTERPRISE MINER, JAVA ORACLE, XML, UNIX, Windows NT.

AtheroGenics Inc, Alpharetta, GA

Jun’04-Jan’06.

Role: Clinical SAS Consultant.

Worked as a SAS Clinical Programmer / Analyst on Cardiovascular, asthma, and arthritis drugs.

As a SAS Clinical programmer, I performed relevant Clinical data analysis on data captured

during clinical trials for Phase I, II and III studies conducted at multiple centers evaluating various

doses of an investigational drug to determine its safety and efficacy.

Responsibilities:

• Working on Phases I & II of Clinical Trials and performed Clinical Data Analysis and

generated SAS Datasets.

• Extensively involved in the process of data validation, where tables and listings produced

by a CRO were analyzed and corrected.

• Provided SAS programming and analysis support for Phase I-II-III clinical trials.

• Designed and created SAS datasets from various sources like Excel datasheets, flat files,

statistical analysis files, tables, listings, and graphs for all phases of clinical drug trials

studies.

• Generating tables and listings for Phase I and Phase II of clinical trials.

• Extracted data from the clinical trial databases and created SAS statistical analysis files

for regulatory submission.

• Developed SAS programs, worked with DATA step to create various SAS data sets and

create temporary files using _NULL_ option in DATA step statement for reporting.

• Developed reports using PROC REPORTS, PROC TABULATE, and DATA _NULL_.

• Designed statistical summary tables, graphs, and patient data listings using base SAS

procedures such as PROC SUMMARY, PROC TABULATE and SAS GRAPH.

• Extensive use of SAS/BASE and SAS/STAT for producing tables, listings, figures, and

generating statistical reports.

• Developed reusable SAS Macros to create tables, graphs, and listings for inclusion in

clinical study reports, and regulatory submissions and maintained existing ones.

• Created derived variables and macro variables (CALL SYMPUT, %LET, etc.).

• Developed case report forms, data validations, and data quality plans. Extracted data

from Oracle using SQL Pass through facility and generated ad-hoc reports.

• Environment: Base/SAS, SAS/MACROS, SAS/ACCESS, SAS/SQL, Oracle 9i, Oracle

Clinical 3.0, Excel/Access 2000, Window NT/ 2000 and UNIX

ENDO Pharmaceuticals, PA

Jan’ 03– Jun’ 04

Role: Statistical/Clinical Programmer

Endo Pharmaceuticals is a specialty pharmacy company with an established leadership in Pain

Management. Involved in Phase II and Phase III trials and an NDA submission.

Responsibilities:

• Data Extraction: Converted MS-Excel tables into SAS data sets. Extracted raw data sets

from ORACLE and Oracle Clinical databases into SAS data files using SAS SQL ‘Pass

through Facility,’ and uploaded SAS data files into ORACLE tables using SAS ‘Dbload’

procedure.

• Provided SAS programming and analysis support for Phase I-II-III clinical trials.

• Performed data analysis, statistical analysis, created listings, graphs and reports using

SAS and various SAS tools - SAS/Base, SAS/Macros and SAS/Graph, SAS/SQL.

• Used sorting and merging techniques on the input data sets for Data Preparation, to get

the required output and then writing the code using SAS tools.

• Produced analysis datasets, listings, tables and graphs for NDA submission.

• Extensively involved in the process of data validation, where tables and listings produced

by a CRO were analyzed and corrected.

• Creation of analysis datasets and generation of DDT (Item – 11) for various studies.

• Produced quality customized reports by using PROC REPORT, SUMMARY and also

provided descriptive statistics using PROC Means, Frequency, and Univariate.

• Conducted statistical modeling for data including linear regression, nonlinear regression,

ANOVA, GLM model etc.

• Went through other programmer’s code and cross-checked the results obtained.

Generated ad-hoc reports.

Environment: BASE SAS, SAS/BASE, SAS/MACROS, SAS/SQL, SAS/ODS, MS-Excel, MS-

Access 2000, Oracle8, SQL, Windows NT/2000, UNIX

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