Data Clinical
Resume:
DARSHAN PANCHAL
******@*****.***
Summary:
. Successful experienced over 7 years in Clinical Research and Analysis,
Design, Development, Testing and Implementation of Clinical Trial
projects in Healthcare and Pharmaceutical industries.
. Strong knowledge involving all phases (I-IV) of clinical trials in
various Therapeutics areas, Clinical Data Analysis, Clinical Data
migration, Generating Statistical Analysis Files, Tables, Listings,
Graphs, Validations, Documentation.
. Worked on SAS/Base, SAS/Stat, SAS/Access, SAS/Graphs and SAS/Macro in
UNIX and Windows environments.
. Worked closely with Statisticians/Data Managers to provide SAS
Programming in analyzing and coordinating clinical trial data,
generating reports, tables, listings and graphs.
. Database Creation and Table Programming for Integrated Summaries of
Efficacy (ISE) and Safety (ISS) and for NDA.
. Modified existing SAS programs and created new programs using SAS
macro variables to improve ease and speed of modification as well as
consistency of results.
. Knowledge of CRF-Annotation with respect to various database designs.
. Knowledge of CRT Dataset creation from clinical trial data, CDISC and
MedDRA for regulatory submissions.
. Familiar with ICH Guidelines and electronic submission standards for
FDA.
. Familiar with Code of Federal Regulations (21 CFR Part 11).
. Experience in Ad-hoc programming for clinical and data management
departments.
. Understanding of statistical aspects in clinical trials: experimental
design, selection of appropriate statistical methodology, sample size
estimation, protocol review, data analysis and summarization and
reporting.
. Excellent command in producing reports employing various SAS
procedures, like Proc Print, Proc Report, Proc Summary, Proc Freq,
Proc Gplot, Proc Tabulate, Proc Mean, Proc Univariate, Proc Transpose,
Proc ANOVA, Proc Regression, Life test, GLM, Proc SQL, Data _NULL etc.
. Excellent communication, analytical, interpersonal, presentation and
problem solving skills.
Technical Skills:
Languages SAS, C, C++, SQL.
SAS Tools SAS/BASE, SAS/MACRO, SAS/SQL, SAS/GRAPH,
SAS/CONNECT, SAS/ACCESS, SAS/STAT.
RDBMS Oracle - CLINICALS, MS-Access, SQL Server and DB2
Internet Software Java, ASP, HTML.
Operating Systems MS Windows NT / 2000 / XP / 98 / 95, MS-DOS and
UNIX
Applications SAS, MS Word, MS Excel, MS Access, MS PowerPoint,
Visual Basic
Professional Experience:
NOVARTIS PHARMACEUTICAL, NJ
Aug'08 - Jun'10
Clinical SAS Programmer
Description:
Novartis Pharmaceutical is one of the leading pharmaceutical companies in
the nation. They deal with a wide range of therapeutic areas like Oncology,
Cardiovascular, Respiratory, Immunology and Infectious Disease etc.
Involved in SAS programming for Clinical Trials on Cardio Vascular
Studies.
Responsibilities:
. Generated Efficacy and Safety Tables, Listings and Figures for
clinical study report for phase II and III of clinical trials using
PROC REPORT, PROC SUMMARY, PROC FREQ, PROC UNIVARIATE, PROC FORMAT,
PROC TRANSPOSE, PROC GPLOT and Company-Developed Standard Macros.
. Developed routine SAS Macros to create tables, graphs and listings for
clinical study reports. Ability to write some common macros that are
useful across multiple studies.
. Reviewed large macro codes for running the programs.
. Perform validation on derived datasets and following the standard
operating procedures during the validation process.
. Performed quality check on SAS programs created for analysis data sets
by performing Parallel Programming using PROC FREQ, PROC CONTENTS,
PROC UNIVARIATE, and PROC COMPARE techniques.
. Performed Statistical Analysis such as ANCOVA, ANOVA, and T-test on
analysis data sets to produce tables and listings as part of ISS and
ISE reports.
. Generate reports either in HTML, PDF or RTF formats according to the
client specifications.
. Worked with Bio-statistician to analyze the results obtained from
various statistical procedures like PROC ANOVA, GLM and mixed models.
. Extensive use of PROC SQL to perform queries, join tables.
. Conducted analysis and generated tables, listings and graphs using
SAS.
. Used PROC REPORT to generate the outputs.
. Ability to work on multiple projects simultaneously and meet the
deadlines as and when required.
. Ability to deliver the TLG's to the clients in the absence of the lead
programmer and participating in off-site meetings.
. Worked closely with Statisticians, Data managers.
Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros, SAS/
Access, MS-Excel.
ELIASSEN GROUP, MA (PFIZER)
Aug'07 - Jul'08
Clinical SAS Programmer
Description:
Project is developed for Pfizer Global Research and Development. Worked in
Phase-II, III of clinical trial for GI disorder. Involved in extensive use
of Base SAS, SAS/Macros, SAS/Graphs and SAS/Stat.
Technical Responsibilities:
. Interact with Statisticians, Data Managers and Clinicians to provide
SAS programming in analyzing the Clinical Trial Data, generate tables,
listings and graphs.
. Generated Tables, Listings and graphs for clinical study report for
phase III of clinical trials using PROC REPORT, PROC SUMMARY, PROC
FREQ, PROC UNIVARIATE, PROC TRANSPOSE, and PROC GPLOT.
. Review the protocol, case report forms (CRFs), statistical analysis
plan (SAP) for Clinical trails.
. Maintain CDISC Analysis Dataset Model (ADaM) standards.
. Created complex and reusable Macros and extensively used existing
macros and developed SAS Programs for Data Cleaning, Validation,
Analysis and Report generation. Tested and debugged existing macros.
. Performed Data validation by checking data distribution by comparing
to a standard data.
. Generate ad hoc statistical analysis reports as required.
. Generated Integrated Summaries of Efficacy (ISE) and Integrated
Summaries of Safety (ISS) reports by pooling data from different
studies of the same studies.
. Extensively used SAS procedures like PROC TABULATE, DATA _Null_, PROC
REPORT and PROC SQL for report generation and PROC UNIVARIATE, PROC
SUMMARY, PROC FREQ, PROC MEANS, PROC MIXED, PROC GPLOT and PROC GCHART
for statistical analysis.
Environment:
SAS/BASE, SAS/SQL, SAS/STAT, SAS/MACRO, SAS/GRAPH, UNIX.
MANKIND PHARMA, NJ
Jun'06 - Jul'07
Clinical SAS Programmer
Description:
Study was related to treatment of Postmenopausal Women with low BMD.
Involved in extensive use of Base SAS, SAS/Macros, SAS/Graphs and SAS/Stat.
Technical Responsibilities:
. Write, test and maintain programs, used for review of data collected
during clinical trials.
. Test, document, review and verify all programs according to SOPs.
. Provided data in SAS transport files, and other appropriate
deliverables and documentation for internal customers, regulatory
submission.
. Worked in Phase II and III of clinical trials and presented results in
standard format.
. Extracted data from Oracle using SQL Pass through facility,
SAS/Access.
. Used Base/SAS to perform sorting, indexing, merging on the data and
generated reports.
. Generated Efficacy and Safety tables.
. Formatted HTML, RTF and PDF reports using SAS output delivery system
ODS.
. Used SAS/Graph and SAS/Stat to generate the plots of variables based
on the symptoms and side effects of the patients.
. Worked on writing, editing, validating and debugging code in BASE SAS
and MACROS.
. Created a SAS customized reports using the Data _Null_ technique for
FDA regulations.
. Created programs for presentation of graphs using SAS/GRAPH. The
presentation of graphs include create a text slides, display several
graphs at one time, combine graphs and text in one display and create
automated presentations.
. Extensively used SAS procedures like PROC TABULATE, DATA _Null_, PROC
REPORT and PROC SQL for report generation and PROC UNIVARIATE, PROC
SUMMARY, PROC FREQ, PROC MEANS and PROC GCHART for statistical
analysis.
Environment:
SAS/BASE, SAS/SQL, SAS/STAT, SAS/MACRO, SAS/GRAPH, Windows, UNIX.
CMED, NJ
Dec'03 - May'06
SAS Programmer
Description:
This project was developed for CMED, which is a well-respected and growing
CRO. Involved in SAS Clinical trials as a SAS Programmer. Created SAS data
sets and performed the analysis using clinical data.
Technical Responsibilities:
. Converted oracle data tables into SAS data files using SAS/SQL and
uploaded SAS data files into oracle tables.
. Involved in the process and IT infrastructures for Phase II, III and
IV Clinical Trials. Ensured quality of dataset at the protocol level
while working to deliver competitive advantage and cost efficient
results.
. Database Creation and Table Programming for Integrated Summaries of
Efficacy (ISE) and Safety (ISS).
. Created reports in the style format using ODS Statements and PROC
TEMPLATE. Generated reports are reviewed by the statisticians and sent
to FDA.
. Generated statistical analysis files, tables, listings, and graphs.
. Develop new or modify SAS programs to load data from the source and
create study.
. Created base programs to set up data. Did data conversions, validation
and corrections.
. Created SAS Customized reports using Data_Null_ technique for FDA
evaluations.
. To develop routine SAS macros to create tables, graphs and listings
for inclusion in clinical study reports and regulatory submissions and
to maintain existing ones.
. Involved in creating electronic submissions project, annotate CRF's
and additional data set descriptions.
. Used procedures like PRO FREQ, PROC MEANS, PROC SORT, PROC ANOVA,
PROC REG, PROC GLM, LIFETEST, PROC PRINT, PROC TABULATE AND PROC
REPORT.
Environment: SAS/BASE,SAS/GRAPH,SAS/STAT,SAS/MACROS, SAS/ACCESS, Windows,
UNIX.
CADILA PHARMACEUTICALS, INDIA
Mar'02 - Dec'03
Clinical SAS Programmer
Description:
Cadila is One of India's most reputed, Research based, Pharmaceutical
Company. Cadila Pharmaceuticals, with its 400 multi-dimensional product
formulations, spanning all major therapeutic groups in Human and 15 in
Animal Health is a leader amongst the Indian Pharma Companies.
Technical Responsibilities:
. Develop new or modify SAS programs to load data from the source and
create study specific datasets, which are used as source datasets for
report generating programs.
. Develop new or modify macros for report generation using SAS/Macros as
per the statistician's requirements.
. Developed SAS programs for statistical analysis and data displays.
. Used SQL pass-through facility to access the data.
. Prepare test plans and test runs for the respective program changed or
created.
. Used PROC PLOT and PROC MIXED for graphical analysis.
. Used PROC Tabulate, PROC Means, PROC Freq., PROC Univariate, PROC
Transpose, PROC Print and PROC Report for reports.
Environment: SAS/Base, SAS/Macros, SAS/Sql, SAS/Access, Windows, SQL.
EDUCATION
M.S. in Computer Science
B.S. in Mechanical Engineering
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