| | - Certified SAS Programmer with 8+ years of professional experience in Clinical Trial projects and SAS Programming in the Healthcare, Pharmaceutical CROs and Biotechnology industries.
- Experience in working on Phase I - IV of Clinical trials including Data manipulation and Statistical Analysis. Good Knowledge on all phases of clinical trials.
- Extensive experience in BASE SAS, SAS MACROS, SAS/STAT, SAS/ACCESS, SAS PC (V9.0), SAS/GRAPH.
- Created and Validated Tables, Listings, Graphs (TLG's) and analysis data set programs of both Safety and Efficacy.
- Experience in working with data according to standards developed by CDISC (SDTM, ADaM) for FDA submission.
- Good understanding of Clinical Trial Phases, clinical protocols/ CRF's/Annotated CRF's, ICH and GCP guidelines, NDA, IND, CDISC, MedDRA, 21 CFR PART 11. Familiar with Electronic submission guidelines to FDA.
- Extensive SAS procedure experience such as PROC SQL, PROC TRANSPOSE, PROC APPEND, PROC FORMAT, PROC SORT, PROC SUMMARY, PROC MEANS, PROC FREQ, PROC IMPORT, PROC EXPORT, PROC CONTENTS, PROC PRINT, PROC TABULATE, PROC REPORT, PROC GPLOT, PROC GCHART, PROC DATASETS.
- Extensive Experience in with Concatenating, Interleaving, Merging Datasets, importing and exporting data files to different formats.
· Experience in handling complex processes using SAS/BASE, SAS/MACROS, SAS /SQL, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/ACCESS - Expertise in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ACCESS and SAS/CONNECT.
- Worked with Departmental stored macros to produce table and listings templates.
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines and hands on experience in implementing CDISC/SDTM standards.
- Experience in analyzing Case Report Forms (CRF) data, Study Protocol, Statistical Analysis Plan (SAP), Clinical Trials, Clinical Data Analysis, Clinical Data migration, Validations and Documentation.
· Proficient in importing or extracting data by connecting SAS System to database systems such as Microsoft SQL,Oracle, Excel, flat files and exporting data to generate dynamic reports in HTML, RTF, XML, Excel, and PDF formats by using SAS/ODS. - Hands on experience on data mapping, pooling and analysis for ISS.
· Worked with financial data, forecasting, decision support systems and documentation. · Knowledge in complete Software Development Life Cycle (SDLC) and data mining. - Extensive experience in generating reports, listings, tables and analysis datasets for safety and efficacy analysis as per specifications using Proc Report, Proc SQL, Proc Means, Proc Freq, Proc Format, and Data _NULL_ methods and validated SAS programs for submissions to FDA (Food and Drug Administration)
- Skilled in using SAS Statistical procedures for analysis of variance, Chi-Square, CMH, T test, Hypothesis Testing, Correlation, and Regression with PROC CORR, PROC GLM, PROC ANOVA, PROC LOGISTIC, PROC TTEST, PROC FREQ, PROC MEANS, PROC UNIVARIATE, PROC NPAR1WAY, PROC LIFETEST, PROC PHREG.
· Experience in RDBMS development including SQL, PL/SQL, and Business Intelligence and data ware housing concepts. - Generated high quality reports in the form of listing, HTML, RTF and PDF formats using SAS ODS.
- Excellent presentation skills with the ability to present and discuss the statistical aspects of clinical trials.
TECHNICAL SKILLS | SAS Tools | SAS 4.1,8.2,9.1.3 SAS/BASE, SAS/MACROS, SAS/STAT,SAS/SQL, SAS/ODS,SAS/GRAPH,S-PLUS,SAS/ETL,PL-SQL | | SAS Procedures | Print, Means, Univariate, Report, SQL, Tabulate, Freq, Sort, Format, import, Copy, C port, Transpose, Compare, G plot | | Programming | C, C++, Perl, RDBMS | | Operating System | Windows 98, Windows 2000,WindowsXp Windows NT, MS DOS, Unix | | Applications: | MS Word, MS Excel, MS PowerPoint, MS Access |
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