Available Excellent Clinical SAS Programmer-Open to Relocate
Name:Ramya
Rate:Open/hr c2c
Availability:Imm
Relocation:Open
PROFESSIONAL SUMMARY:
· Having 6 years of SAS Programmer Experience with strong emphasis in data analysis, Clinical trials and Health Care data.
· Strong expertise in design, development, analysis, testing and implementation of various SAS applications with in Clinical and Health care domains.
· Good knowledge of clinical trial study, Design and analysis that lead to NDA submissions.
· Knowledge of FDA regulations (CFR) Title 21, part 11 for the pharmaceutical industry.
· Superior knowledge of drug development process and clinical trial methodology.
· Knowledge of statistical analysis techniques for clinical studies, and excellent experience in analyzing safety & efficacy data for Phases (I-III) of clinical trials.
· Knowledge of clinical trial data such as demographic data, Adverse events(AE), Serious Adverse Events(SAE), Lab data and Vital Signs.
· Experience in SAS/BASE, SAS/MACROS, SAS/STAT, SAS/SQL, SAS/GRAPH, SAS ACCESS, and SAS/ODS in windows and UNIX environments.
· Knowledge of CRT Dataset Creation from clinical trial data, CDISC and MedDRA for regulatory submissions.
· Develop/verify the ADaM datasets based on the specifications provided by the study Biostatistician.
· Knowledge of producing external files and customized reports using various SAS procedures like Proc Report, Proc Print, Proc tabulate, Proc Means, Proc summary, Proc Freq, Proc Univariate, Proc SQL, and Proc Transpose.
· Proficient in debugging, storing and managing SAS data files, merging SAS data sets, SAS Formats, and SAS Informats.
· Proficient in producing Reports through ODS either in HTML, PDF or RTF formats according to the client specifications and good knowledge of CDISC standards.
· Good Experience in understanding the PROTOCOLS, SAP's and CDISC Process (SDTM, ODM and ADAM Models).
· Proficient in generating tables, listings, and graphs adhering to the Statistical Analysis Plan (SAP), Standard Operating Procedures (SOPs), and departmental guidelines.
· Have knowledge in creating, export files, XML files using PROC CDISC for FDA submission.
· Extensive experience in creating SDTM datasets from raw datasets.
· Creating CRT SAS analysis datasets by adding derived variables to source eCRF data as per SDTM standards.
· Really good understanding and experience in mapping raw data into SDTM and ADaM datasets as per CDISC standards (SDTMIG 3.1.2 and ADaM IG v1.0).
· Thorough hands-on experience in using SAS/ODS to generate different files including XML, RTF, MS Excel, PDF and HTML.
· Developed specs to map a clinical study data in compliance with SDTM and annotated CRF accordingly and created Analysis datasets as per ADaM specifications.
· Highly motivated, Organized Team player with excellent analytical, communication and leadership skills.
· Excellent in analytical, presentation, and problem solving skills and work independently as well as in a team.
TECHNICAL SKILLS:
SAS Tools : SAS V9.1.3, Base SAS, SAS/SQL, SAS/MACROS, SAS/STAT, SAS/GRAPH,
SAS/ODS, SAS/BASE, SAS/ACCESS
SAS Skills : SAS 9.1/SAS 9.2
Operating Systems : Windows 2003 Server, Windows NT/2000/XP/Vista/Windows7, UNIX.
Databases : Oracle, MS SQL SERVER & MS ACCESS.
SAS Procedures : DATASETS, REPORT, PRINT, FREQ, MEANS, SUMMARY, CONTENTS,
COMPARE, TRANSPOSE, SQL, REG, CORR, UNIVARIATE, TABULATE,
CHART, FORMAT, IMPORT, EXPORT, APPEND, GPLOT, ANOVA
Regards
Praveen
SPARTAN SOLUTIONS INC
2851 Stage Village Cove Ste 22, Bartlett TN 38134.
Direct: 901.405.3050
eFax : 901.531.8255
Email ID: psande@spartansolutions.net
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