- Have fourteen years' experience as a Statistical/SAS Programmer/Analyst.
- Possesses strong background in Clinical Trials, SAS, SQL, UNIX, WIN NT, VM/CMS,
MVS/TSO and VAX/VMS.
- Generate Reports, Listings, and Graphs required for Clinical Trials.
- Mapping Variables from the Raw Datasets to Analysis Datasets for Clinical Trials.
- Work on the Safety, Integrated Summary Safety, Efficacy and Integrated Summary Efficacy programming.
- Program various statistical procedures required for Safety and Efficacy analysis.
- Migration of Data from One Operating system to another Operating System.
- Development of 2-D, and 3-D graphs using the SAS Graphic Software.
- SAS/SQL Creating Tables, and Views Using Sub queries and Joins.
- Execution of programs with Data Null Step, SAS Array Processing, SAS
- Merge SAS Macro and DATA Manipulation across MVS/CMS/PC/UNIX/VAX/MAC Platform.
- Operating Systems: VAX/VMS, UNIX, MVS, VM/CMS, Mac, DOS, OS2/Windows
- Languages: SAS, FORTRAN, Pascal
- Databases: Oracle
- Tools and Libraries: Microsoft Outlook, Word, Excel, Word Perfect, AutoCAD, Foxpro, Lotus1-2-3,
- Quattro Pro, Sigma Plot, and Mathematica, FTP, SAS Macro Programming: Advanced Topics, Getting Started with the Output Delivery System and Advanced Output Delivery System Topics.
SAS Programming Consultant
- Reviewed CRT datasets against the bank CRF pages for all pages in the CRF book.
- SDTM variables were annotated on the PDF blank CRF for special purpose datasets such as domains datasets as well as trial model designs datasets, for intervention datasets, for findings datasets and supplemental qualifiers datasets of hepatic oncology study and renal impairment oncology study.
- Wrote specifications on the excel spread sheet to map variables from CRT datasets to SDTM datasets such as special purpose datasets, for intervention datasets, findings datasets, intervention datasets and supplemental qualifiers datasets using SDTM Mapping specifications for hepatic oncology study and renal impairment oncology study.
Statistical Programming Consultant
- Worked in the oncology and anti-Inflammatory therapeutic areas.
- Reviewed SAP, analysis dataset specifications and protocols. Developed and validated analysis datasets required for efficacy and safety analysis. Produced and checked safety and efficacy tables, listings and graphs.
- Produced graphs using Gplot, proc greplay and the annotate dataset. The standard macros, many SAS procedures such as proc report, proc print, proc sql, proc lifetest, various SAS statements and functions are used to program the analysis datasets, tables and listings.
Senior Statistical Programmer
- Reviewed and provided comments required for the SAP, Analysis dataset specifications and Protocols. Created derived datasets using CDISC SDTM and Created derived datasets without using CDISC. Generate and verified Safety and Efficacy tables, listings and graphs required for oncology, anti-infective and Pain/anti-inflammation Therapeutic Areas.
- Created Graphs using Proc Gplot. The Standard Macros, Proc Report, Proc Print, Proc SQL, various SAS Statements, and Functions are used to program the analysis datasets, tables and listings.
Statistical Programming Consultant
- Created safety tables and graphs, reviewed SAP and Protocol required for Breast Cancer Study.
- Created Graphs using Proc Gplot. The Standard Macros, Proc Report, Proc Print, Proc SQL, Data Null , various SAS Statements, and Functions are used to program the analysis datasets, tables and listings.
Principal Statistical Programmer/Analyst
Created some tables and validated other programmer's tables and listings for E5564-A001-201 Anti-Infective Study. Weekly meetings has been attended, reviewed SAP, and protocol and provided comments. Errors in the database had been checked while working on tables. Junior programmers who needed my guidance had been helped.1
Senior Statistical Programmer/Analyst
- Got acquainted with the Eisai system and understood the existing programs and global macros.
- Created new macros which are used across studies. Assisted new hires in learning SAS/UNIX.
- Reviewed and provided comments on protocol and statistical analysis plan to the statistician, created randomization dataset, and worked closely with the clinical for the review of the tables and data listings, coordinated electronic data transfer from CRO and Eisai Inc, UK for E2051-A044-001 study.
- Coordinated electronic data transfers form/to central labs/CRO to/from Eisai Inc., performed QC
- and query generation of electronic lab data, and managed coding of adverse events and concomitant medications for sepsis study.
- Worked with Statistician in creating standards for labs, non study medications, demographics, and study termination analysis datasets and Working on the standards for AE analysis dataset for study E7389-A001-101 and E7389-A001-102
- Created SAS programs for analysis tables, and listings E2051-A044-001 CNS , E7070 A001-106 Oncology , and E7389 A001-101 Oncology studies. Write the edit check program for the edit specs which are not covered by data management.
- Presented the SAS Programming directory structure to the SAS/Statistical Programmers and Statisticians. Got the feed back from the group and worked for the final SAS programming directory structure. Prepared the documentation required for the SAS Programming directory structure.
- Study E2051-A044-001: Broke the blind code, checked the treatment assignment and created the randomization dataset.
- Participated in the monthly meeting of E7389-A001-101, E7389-A001-102, E7070-A001-106 and E2051-A044-001 studies. Kept the team informed of the progress of programming and data issues.
- Produced adhoc tables for E7070-A001-106 annual report requested by regulatory.
- Adapted existing macros. Created the following macros:
- Contents: To print the contents of all the tables in the database.
- Print: To print data of all the tables in the database. For the particular number of observation, Please specify number of observations in the macro. Other wise it will print data of the all tables in the database.
- Study format: This macro convert the study code list from the oracle database to sas formats and stores the formats in the study format directory.
- Data format: The macro converts oracle table to SAS dataset and add the associated formats and labels to the SAS dataset. The associated formats and labels are obtained from the Meta data table.
- Coordinated and checked the lab data obtained from the doctors laboratory for study E2051-A044-001. Clarified the data issues with the doctor's laboratory. Coordinated and checked the ECG data obtained from the EISAI Inc London and Created ECG analysis dataset for E2051-A044-001 study. The ECG analysis dataset contains unique record for each time point.
- Study E2051-A044-001: Created adverse event SAS analysis dataset using media dictionary. Sent the term which is not coded automatically to the data management. Created nonstudy medication SAS analysis dataset by merging with the dictionary. Obtained approval for non-study medication terms from the study directory.
Internal: Effective Communciation, Respecting Diversity, and Preventing Harassment.
External: SAS Macro Programming: Advanced Topics, Getting Started with the Output Delivery System and Advanced Output Delivery System Topics.
- Worked on the Phase III Clinical Trials Safety analysis programming in the Psychiatry and Central Nervous System therapeutic areas.
- Reviewed Protocols, Mapping Document, and Statistical Analysis plan. Created and validated various analysis datasets of various studies. Mapped variables from the various studies analysis datasets to Integrated Summary Safety ISS analysis datasets variables.
- Produced tables and listings required for various studies and for ISS. Created UNIX script file using SAS Software to compare previous version tables with the latest version tables.
- Validated others analysis datasets, tables, and listings of various studies and ISS.
- Used Proc Compare to compare the previous version and latest version datasets.
- Created the dataset and format catalog transport files required for NDA submission using Proc Copy and Proc Cport.
- Programmed Statistics using Proc Univariate, Proc GLM, Proc ANOVA, Proc Means, Proc PHreg and Proc Freq.
- Did Survival Analysis and Kaplan Meier Estimates using Proc Life Test.
- Created Graphs using Proc Gchart, Proc Gplot, Annotated datasets, and Proc Greplay.
- Used the Standard Macros, Proc Report, Proc Print, Proc SQL, Data Null , various SAS Statements, and Functions to program the analysis datasets, tables and listings.
- Created the datasets for the Annual report using various SAS statements as per physical model for Adverse Event, Demog, Lab, Testdrug, and Summary for various studies of various drugs in the anti-infection therapeutic area of Phase IV clinical trials.
- Validated and cross checked the safety tables obtain from Clinical Research Organizations
- for various studies of various drugs in the anti-infection therapeutic area of Phase IV clinical trials.
- Modified others tables and listings required for the safety and efficacy analysis.
- Statistics were programmed using Proc Freq, Proc Mean, Proc GLM, and Proc Univariate.
- The reports and listings were generated using Proc Tabulate, Proc Report, Proc Means, Proc Freq, Proc Univariate, Proc Print, Data Null , Macro statements, Macro functions, and Standard Macros.
- Generated the safety reports using CDARS system.
- Programmed edit checks and ran edit checks using discrepancy management system.
- Migrated SAS data and SAS programs of all Protocol Studies from the Win NT Operating System to the VAX/VMS Operating System using proc Cimport, proc Cport, Proc Copy, and using SAS Statements and Functions. That includes Macro statements and Functions.
- Created analysis datasets, Generated Listings, Tables, Statistics and Graphs required for the Phase III and Phase IV clinical trial Studies.
- The reports and listings were generated using Proc Tabulate, Proc Report, Proc Print, Data Null , and Standard Macros.
- The statistics were calculated using Proc Means, Proc Freq, Proc GLM, Proc Life test and Proc Univariate.
- The graphs were created using Proc Gplot, Proc Gchart, and Annotated datasets,
- Used macro statements and macro functions.
- Converted Excel files to SAS dataset using Proc Access.
- Migrated SAS data and SAS programs of all studies from the Win NT Operating System to the Unix Operating System and Validated.
- The data being migrated using proc Cimport, proc Cport, Proc Copy, and using SAS Statements and Functions. That includes Macro statements and Functions.
- Generated the exported SAS Listings and the exported SAS Tables on the Unix Operating System, Printed, Documented and Validated randomly with the same Listings and the same Tables on the Win NT Operating System.
- Created analysis datasets, Generated Listings, Tables, Statistics and Graphs required for the Pulmicort Turbuhaler Phase III and Phase IV Studies.
- The reports and listings were generated using Proc Tabulate, Proc Report, Proc Print, Data Null Macro statements, Macro functions, and Standard Macros.
- The statistics were calculated using Proc Means, Proc Freq, Proc GLM, Proc Life Test and Proc Univariate.
- The graphs were Created using Proc Gplot, Proc Gchart, Annotated datasets, macro statements and macro functions.
Operating Systems: Windows, VAX/VMS and VM/CMS
- Created the data sets with flags, calculated various statistics and generated the reports, the listings and the graphs required for ISS of Lamsil Solution Nail Fungi Phase III Studies.
- Generated the efficacy and safety reports, listings and graphs required for Sand immune Drug RA Symptoms Phase III Studies and various clinical pharmacology studies.
- The reports and listings were generated using Proc Tabulate, Proc Report, Data Null Proc Print, Proc SQL, Macro Statements and Functions.
- The statistics were calculated using Proc Means, Proc Freq, Proc GLM, Proc ANOVA and Proc Univariate.
- The Graphs were created using Proc Gplot, Proc Gchart, Annotated Data sets and Macro Statement and Functions. The analysis data sets were created using various SAS Language Statements and functions.
- Data transfer for Chib studies checked and validated the listings, reports and derived data sets generated by Pharmaco.
Operating System: VAX/VMS
- Responsible for data pooling, creating data sets and generating reports for an Anti-Hypersensitive Drug Study Protocols using Proc Tabulate, Proc Report, Data Null , SAS Arrays, Proc SQL and Macros.
- Converted oracle data to SAS data, created SAS access descriptor files, and SAS view descriptor files using SAS/ACCESS.
Operating System: HP-UNIX
- Pooled, cleaned and validated Concurrent Med Data, Physical Data, Acct Data, and Dosing Data of various Arthrotec Studies using macros and various SAS statements.
- Created custom reports on Daypro Drug using Data Null , Arrays, SQL and Macros.
Operating Systems: VM/CMS and OS2/Windows
- Used Data Null , SAS Arrays, SQL, and MACROS
- Created custom reports on several types of data, including adverse event, concomitant medication, ECG, treatment evaluation, patient record, index and scale data.
- Responsible for data reports for control of Perennial Rhinitis Symptoms of Parkinson Disease clinical trial Permpexole Tablet and of Atrovent Clinical Trial Nasal Spray .