Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Professional Skills:
Professional Experience:
Generated Tables, Listings and Graphs using various procedures like Proc Freq, Proc
Report, Proc Tabulate, Proc Univariate, Data_null_, and Proc Gplot for final FDA
study reports.
Created SAS Macros and modified the existing ones relating to multiple studies.
Produced tables listings graphs for Integrated Summaries of Efficacy (ISE) and
Safety (ISS).
Maintained appropriate study application documentation.
Created reports in the style format using ODS statements and PROC TEMPLATE.
The generated reports are reviewed by the statisticians and sent to FDA.
Provided SAS programming and statistical support to clinical studies group on
projects.
Generated derived data sets for the statistical analysis as per SAP.
Performed Data Validation and Data Cleaning by Peer-Reviewing.
Experienced in validating programs and in writing competing codes to re-check the
statistical values of tables.
Successfully validated TLG’s and CRT’s through independent validation using Proc
compare and departmental standard macros.
Proficient in indicating the input data sets, setting, sorting and merging techniques to
get the required report.
Generated Ad-hoc reports and browser viewable reports using SAS\ODS.
Successfully handled multi-projects/tasks at a time.
SAS Programmer/Analyst
Analyzed the Clinical data for Phase II and Phase III trials through SAS
programming.
Performed statistical analysis, wrote SAS code for DATA Management and reporting,
and performed validation, including testing SAS code.
Created SAS Macros and SAS Graphs. Used proc report to generate reports.
Produced tables listings graphs for Integrated Summaries of Efficacy (ISE) and
Safety (ISS).
Created CRT’s (Case Report Tabulations) using CDISC standards for submission to
the FDA.
Extensively used Dynamic Data Exchange (DDE) for importing data in Excel sheets
into SAS.
Used SAS Macro facility to produce weekly and monthly reports.
Performed Data Validation and Data Cleaning on Clinical Trial data.
Debugged SAS programs using Data_Null_, PUT statements in code reviews and
testing.
Produced accurate, precise tables and listings for clinical Study Reports by
conducting, documenting and reporting computer validation inspections in
compliance with 21 Code of Federal Regulations (21CFR) Part11, FDA, data
transmission and integrity check for the existing and in-house Clinical Trial Systems.
Produced highly formatted and highly customized reports using Data_Null_.
Developed routine SAS macros to create tables, and listings for inclusion in Clinical
study reports and regulatory submissions and maintained existing ones.
Performed SAS programming using techniques as SAS Base, SAS Macro, data
manipulation techniques, and statistical procedures (e.g., Proc Means, Proc freq, Proc
Report).
Produced RTF, MS WORD and HTML formatted files using SAS/ODS to produce
ADHOC reports for presentation and further analysis.
Generated graphs using SAS/GRAPH.
Developed SAS Macro programs to generate reports, tables and listings for Clinical
and Bio statistical review and maintained the existing ones.
Optimized performance using Data Validation and Data Cleaning.
Wrote Macros to replace repetitive codes. Used Proc Report to generate reports.
Proficient in sorting and merging techniques to get the required report.
Extensive experience with the SAS programming, with various SAS procedures in
Base SAS and thorough knowledge of SAS Macro language.
Developed routine SAS macros to create tables, graphs, listings for inclusion in
Clinical study reports and regulatory submissions and maintained existing ones.
Created and extracted oracle tables from SAS and within Oracle by using SQL Pass-
Through facility.
Created survival graphs in MS-Excel by transporting SAS datasets to Excel
spreadsheets.
Used SQL and SQL Pass-Through facility to retrieve the data from Oracle database
for reporting
Created and maintained SAS Datasets that are extracted from an oracle Clinical
Database.
Prepared clinical data listings and summaries for statistical analysis and analyzed
clinical data using SAS system.
Performed statistical analysis, wrote SAS code for data management and reporting,
and performed validation, including testing SAS code.
Used SAS for processing data, data analysis, generating reports, graphics, and
statistical analysis.
Implemented statistical analysis plans and specification documents.
Developed efficient, well-documented, readily comprehensible and modifiable SAS
code using SAS/Base and SAS/Macro facility.
Extracted data from Oracle using SQL within SAS to be analyzed and exported to
Excel for further analysis.
5
Produced quality customized reports by using Proc Tabulate, Proc Report, Proc
summary and also provided descriptive statistics using Proc Means, Proc Freq and
Proc Univariate.
Involved in clinical trials programming of data tables and listings for reporting on
safety and efficacy.
EDUCATION: