- 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.
- 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
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
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
- 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
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
- 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.