PROFESSIONAL SUMMARY Sr. SAS programmer with over 6 years of experience in SAS programming and experience in analysis, design, development, testing and implementation of Clinical Trial Projects in Pharmaceutical industries. Knowledge of the drug development process with strong experience of analyzing and reporting in phase I, II, III of clinical trial data. Experienced in CDISC SDTM mapping from raw datasets, SDTM I.G and annotated eCRF. Involved in creation and validation for SDTM and ADaM data sets, tables and listings. Developed general-purpose and ad-hoc SAS programs/macros for the extraction, manipulation, analysis, presentation and validation. Extensive experience in using various SAS tools like SAS/BASE, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS ODS, SAS/ACCESS, SAS/CONNECT, and SAS/SQL. Provided programming expertise in generating Tables, Listing and Figures TLF's as per the mock shells and SAP for ISS and ISE. Knowledge of CRT Dataset Creation, CDISC for regulatory submissions. Experienced in OpenCDISC validator tool to ensure the compliance with CDISC standards for SDTM, ADaM, Define.xml. Knowledge of FDA regulations, ICH Guidelines and GCP requirements. Very good experience in analyzing Case Report Forms CRF data, Clinical Trials, Clinical Data Analysis, Clinical Data migration, Validations and Documentation. Highly adaptive to a fast paced team environment and with a proven ability to work in a team environment and individually. Have excellent communication and written skills.
SAS9.1.3,SAS9.2,SAS/BASE,SAS/MACROS,SAS/SQL,SAS/STAT,SAS/GRAPH, SAS/ODS, SAS/ACCESS.
CONTENTS, PRINT, SORT, IMPORT, EXPORT, DBLOAD,
DATASETS, TRANSPOSE, PRINTTO, FORMAT, SQL,REPORT, TABULATE, MEANS, FREQ, SUMMARY, ANOVA,CHART, PLOT, GPLOT, GCHART
UNIX, WINDOWS 98/XP/2000/NT
ORACLE 8/8i/9i, ORACLE CLINICAL
SAS 8/9, SAS Enterprise Guide, C, PL/SQL
MS-OFFICE, Word, Excel, PowerPoint, HTML
: PROFESSIONAL EXPERIENCE
Role: Sr. SAS Programmer
Responsibilities: Worked extensively on CDISC SDTM domains and generated the xpt files. Created ADaM datasets using CDISC standards. Well-versed in using OpenCDISC validator tool to ensure the compliance with CDISC standards for SDTM, ADaM, Define.xml. Reviewed Protocol, DST Data Specifications Table , DVM Data Validation Manual , Edit Check document, Quality Plan for TLFs, SAP, SOPs, and eCRF layout and eCRF completion Guidelines. Annotated eCRF according to SDTM standards. Developed DDT's Data Definition Tables for SDTM datasets. Worked with Data cleaning and data validation on the work developed by other programmers. Developed SAS programs for Edit Checks, also validated listings, summary tables for drug study. Performed quality control checks on program code and outputs produced by other team members. Created macros to ensure the variables are as per CDISC guidelines. Extensively involved in creation and validation of Tables, Listings and Graphs TLG and Ad-hoc reports. Extensively used PROC SQL, PROC TRANSPOSE, PROC MEANS, PROC UNIVARIATE, PROC FREQ, PROC PRINT, and PROC COMPARE for checking the assumptions and statistical analysis. Generated programs in MACROS to generate graphs, listings, quality tables for clinical study reports and regulatory submissions. Customized existing SAS programs and created new programs using SAS MACRO facility to improve simplicity and pace of modification as well as reliable solutions. Developed programs for safety and efficacy tables such as Adverse events, Labs, Dose Exposure tables, vitals, ECG, Demographics, Disposition and baseline characteristic tables. Handled Dropouts and Missing Data by using Last Observation Carried Forward LOCF . Used SAS ODS to report outputs in different formats like RTF, PDF, and HTML. Created formats for the coded data and used PROC SQL for data validations. Worked with ARRAYS, first. Variable and Last. Variable.
Role: Sr. SAS Programmer
Responsibilities: Involved in creation and validation of data sets SDTM and ADM . Developed specifications for database in CDISC format and involved in programming datasets in CDISC format STDM model 3.1 . Involved in running and interpreting WEBSDM checks for derived data sets. Involved in running and interpreting OPEN CDISC VALIDATOR for derived sets. Importing the data in to SAS from Excel Spreadsheet using PROC IMPORT. Program, test, and document databases in accordance with programming standards and validation procedures. Validated derived datasets, tables, listings and graphs as per specifications and mockups in SAP Generated various Efficacy and Safety Listings, Tables and graphs for several studies Used procedures such as Freq, Means, Univariate, GLM, Mixed, T-test, Report, and Transpose to prepare various statistical results in RTF formats Involved in creating the data definition table and SAS transport files for submission as a part of the final report to the FDA Producing Top line efficacy results and creating analysis dataset for these efficacy results as per the specifications of client Created ad-hoc reports using SAS
Role: Sr. SAS Programmer
Developed standard agreement documents to facilitate data transfers from External vendors. Created SDTM Domains, ADaM datasets, TLF's as primary programmer and validated as secondary programmer. Developed efficient, well documented, readily comprehensible and modifiable SAS code using SAS/BASE and SAS/MACRO facility. Used Data Null technique for producing customized reports. Served on various internal committees to develop macros and standardize processes. Extensively used SAS procedures like PROC FREQ, PROC MEANS, PROC REG, PROC CORR, PROC TABULATE and PROC REPORT. Generated statistical analysis, tables, listings and graphs for Phase I-II clinical studies. Worked with various SAS modules such as SAS/BASE, SAS/STAT, SAS/GRAPH, and SAS/ MACROS to generate statistical deliverables. Developed ad-hoc reports as per the Biostatistician and client requests. Documented programs while being compliant with ICH-GCP guidelines and SOPs. Performed data checks as needed, to ensure integrity and correctness of data displays. Created project specific macros and formats to ensure consistency and integrity of data.
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