SUMMARY:

• Certified SAS programmer with 6 years of experience within the pharmaceutical/biotech industry or CRO
• SAS programming experience in generating Analysis Datasets/SDTM/ADaM
• Experience in producing and validating Tables, Listings and Graphs TLG's using Base SAS, SAS/Graph, SAS/Macros and SAS/ODS according to Statistical Analysis Plan SAP .
• Broad Knowledge of Life Sciences and drug development process from protocol through FDA submissions in the clinical trial process Phase I IV
• Extensive Knowledge of both CDISC SDTM and ADaM models.
• Experience in both Clinical SAS programmer and Statistical programmer
• Knowledge of creating Case Report Tabulation CRT's using CDISC standards
• Experience in Phase I - IV clinical trials and FDA submissions
• Experience in Producing RTF, HTML and PDF formatted files using SAS/ODS.
• Knowledge in creating tables and listings programming for ISS Integrated Summary of Safety and ISE Integrated Summary of Efficacy to the FDA.
• Experience in SAS/BASE, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/STAT, and SAS /ODS in Windows and UNIX environments.
• Knowledge of MedDRA, WHO-DRUG, CTC Common Toxicity Criteria , FDA regulations 21 CFR part 11 , ICH guidelines and GCP requirements in new drug development and application process
• Extensive experience on generating Patient narratives and .XML outputs for FDA regulatory submissions
• Working experience in Data cleaning and edit checks
• Worked with different clinical trial domains like Demographic, Adverse Events AE , Serious Adverse Events SAE , Disposition, Medical History MH , ECG, Exposure Ex , Concomitant medication CM , Vital Signs VS and Laboratory Data lab data . Etc.
• Working knowledge of database design/structures.
• Proficient in extracting data from Oracle Database into SAS data files using SQL Pass-through facility.
• Ability to work well with others and independently
• Worked in various therapeutic areas like Oncology, Vaccines, Alzheimer's, Immunology, CNS, and Endocrinology, Ophthalmology and Gastroenterology Etc.
• Excellent organizational and communicational skills with high self-motivation, team leadership experience.

TECHNICAL SKILLS:

• SAS : Base/SAS, SAS/MACRO, SAS/ODS, SAS/GRAPH, SAS/STAT, SAS/SQL
• Databases: Oracle, SQL Server 2000, MS Access
• Languages: C, SQL, PL/SQL, HTML, Visual Basic 6.0
• Operating Systems: Windows 95/98/NT2000/XP, UNIX

PROFESSIONAL EXPERIENCE:

Confidential

Clinical SAS Programmer

• Worked on generating raw datasets on CDISC SDTM standards and analysis datasets on ADAM Standards
• Involved in Statistical programming and validation of Analysis Datasets and Tables, Listings, Graphs TLG'S
• Created SDTM datasets for Patient narratives.
• Created Patient narratives and generated .XML outputs for FDA regulatory submissions.
• Assisted in preparation of various study specific documents
• Assisted programming for ISS Integrated summary of safety tables and listings
• Involved in Data cleaning and Edit checks

Confidential

Senior Statistical Programmer.

• Developed Specifications for analysis datasets as per company standards
• Generated analysis datasets as per Client standards
• Analyzed clinical trials data and generated Tables, Listings, and Graphs TLG's as per the Statistical Analysis Plan SAP .
• Performed validation of datasets and Tables, Listings, Graphs TLG's
• Involved in Documentation
• Generated Graphs by employing SAS/GRAPH procedures including PROC GPLOT, PROC GCHART and created HTML,RTF,PDF reports using SAS/ODS.
• Used Macros for generating Analysis Datasets, Tables, Listings and Graphs
• Used SAS/STAT procedures such as UNIVARIATE, FREQ, MEANS, GLM, ANOVA and LIFETEST

Confidential

SAS Programmer

• Involved in Creation of Datasets, Tables for ISS and ISE.
• Involved in Listings and Graphs for phase I to phase IV trials.
• Extensively involved in the process of validation of Datasets and validation of Tables and Listings
• Involved in Review of mock-shell development, derived dataset specifications, programming specifications, and other process supporting documents.
• Extensively involved in Data cleaning and Edit checks
• Extensively used SAS/ODS to produce HTML, PDF and RTF format files.
• Worked with biostatistician for statistical analysis and data managers for data cleaning

Confidential

Clinical SAS Programmer

• Produced data Listings and Summary tables.
• Involved in documentation of several studies phase I to phase III trials .
• Providing statistical support for generating eRPL book marking for FDA submission studies.
• Extensively involved in Documentation of studies.
• Reviewed Protocol and Case Report Forms to identify irregular data entry errors of clinical trial data.
• Created Safety customized reports for FDA regulatory submissions.
• Effectively used many SAS functions like SCAN, SUBSTR, and TRIM.
• Used Proc Import for importing data from Excel sheets and CSV files.
• Preliminary data validation clinical data quality checks is done on the clinical trial data using SAS/SQL
• Performed Ad-hoc Programming and Reporting.
• Designed flowcharts indicating the input data sets and the techniques that would be used sorting, merging, etc. to get the desired output
• Generated and validated patient profiles for the different studies

Confidential

SAS Programmer

• Involved in Data Cleaning and Edit checks
• Worked on creating Analysis Datasets
• Generated Tables, Listings and Figures TLF's
• Created ad hoc programs to provide information to the project team and/or client, as required.
• Involved in Validation of Tables and Listings for clinical study reports.
• Developed and modified different standard safety reports after study initialization and data extractions.