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PROFESSIONAL SUMMARY
Experience in SAS/BASE, SAS/MACROS, SAS/GRAPH, SAS/STAT, SAS/ETL, SAS/SQL, SAS/ACCESS,
SAS/CONNECT, SAS/ODS, SAS/ENTERPRISE GUIDE, SAS BI, SAS/ASSIST in WINDOWS environment
Certified in Clinical Trial in SAS programming with good knowledge of advanced statistical
methodologies applied in Pharmaceutical, Biotech, and clinical Trials.
Understanding of the client's vision, goals, limitations, data sources and time lines.
Created Analysis Datasets using PROCEDURES like PROC SQL, PROC SUMMARY, PROC TRANSPOSE,
PROC SORT, PROC FORMAT.
Have conducted analysis and processing of data using procedures such as PROC COPY, PROC
PRINTTO, PROC DATASETS, PROC CONTENTS and PROC COMPARE.
Solid understanding of statistical concepts and proficient use of various statistical and stored
procedures like proc sql, proc report, proc freq, proc means, proc tabulate, proc transpose, proc
plot, proc chart, proc contents, proc dataset, proc format, proc import, proc export, proc print,
proc summary, macros, proc sort, drop, keep, retain, date manipulations, formats, in formats and
SAS/STAT procedures like proc anova, t-test.
Strong knowledge of clinical trial data and good experience in designing, developing and analyzing
the data, debugging the errors, reviewing the SAS code.
Extensive Experience in creation of TFL (Table, Figure and Listings) using PROC REPORT, DATA
_NULL.
Well experienced in analysis of clinical trial data and generating reports, graphs, listings,
summaries, tables and standard operating procedures based on company standards in compliance
with 21 CFR Part 11, FDA and other GCP Guidelines.
Generate new datasets from raw data files imported or modify existing datasets using SET, SET/SET,
MERGE, MODIFY, UPDATE, SQL, APPEND and HASH.
Hands on experience in New Drug and Drug release process from Investigational New Drug
submission to getting approved from FDA.
Experience in creation of Reusable SAS Macros using SAS Macro Facility to reduce the overall
development time.
Profound knowledge of Clinical trial data, Protocol, CRF and other trial related terminologies.
Proven experience in validation of database creation and report programs using validation SOPs.
Experience in Annotation of CRF and creation of data-set definitions for study submissions.
Generated various graphs using SAS/GRAPH procedures like PROC GPLOT, PROC GCHART and PROC
BOXPLOT.
Ability to work in cohesive environment with excellent verbal and written communications skills.
Clinical Data Science graduate with knowledge of FDA regulations, ICH, 21 CFR part 11 guidelines,
data mining, data delivery, and protocols.
Proficient in data coordination activities and data validation on SDTM projects using SAS.
Experience in statistical analysis and database management using statistical programs (e.g., SAS)
and database software (e.g., Excel, Access).
Expertise as a Clinical Research Assistant in maintaining clinical systems that track compliance and
performance with project timelines.
SKILL HIGHLIGHTS
SAS Tools: SAS v.9.1, v9.2, v.9.1.3 SAS/EG 7.1(Base, Macro, ODS, ACCESS, CONNECT, GRAPH,
STAT), SAS-DI (Data Integration Studio) 4.9, SAS MC (Management Console) 9.4, Clinical SAS, R,
SQL,Tableau,SAS/BASE, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/ODS,SAS Procedures, Proc Freq,
Means, Format, Contents, Compare, Print, Summary, Univariate, Sort, Transpose.
Operating Systems: UNIX/ Windows XP Professional/Windows 7 Pro/Windows 10 Pro
Languages: SQL, PL/SQL, C, C++, SAS
Microsoft: Access, Word, Excel, Outlook, Power Point, SharePoint, MS Office
EXPERIENCE
Environment: Base SAS v9.2, SAS/Macros, SAS/SQL, SAS/ACCESS, SAS/STAT, SAS/ODS, Windows XP.
EDUCATION