CONSULTANT NAME

SUMMARY
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Certified SAS Programmer with over eight years of experience in Analysis, design, development,
testing and validating the applications.
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Strong knowledge involving all phases (I-IV) of clinical trials.
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Worked on SAS/Base, SAS/Stat, SAS/Access, SAS/Graphs and SAS/Macro.
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Expertise in analyzing and coordinating clinical trial data, generating reports, tables, listings and
graphs.
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Knowledge of CRF-Annotation with respect to various database designs.
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Knowledge of CRT Dataset creation from clinical trial data, CDISC and MedDRA for regulatory
submissions.
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Reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21
CFR, Part II).
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Optimized performance using Data Validation and Data cleaning on Clinical Trial data using
Statistical procedures like PROC FREQ, PROC MEANS, and PROC UNIVARIATE.
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Involved in writing and updating Standard operating procedures (SOP) for reviews and approvals.
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Experience in Ad-hoc programming for clinical and data management departments.
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Knowledge of Programming languages such as C and UNIX SHELL.
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Highly motivated individual with excellent organizational and interpersonal skills.
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Possess strong ability to quickly adapt to new applications and platforms.
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Good team leader with strong analytical and communication skills.
TECHNICAL SKILLS
SAS Tools:
SASV8, V9, SAS/BASE, SAS/ACCESS, SAS/SQL, SAS/MACROS,
SAS/GRAPH, SAS/STAT, SAS/ODS.
Databases:
Oracle Clinical, Clin-Trial, SQL server, Oracle7x/8x.
Operating Systems:
UNIX, Linux, Windows98/2000/NT/XP.
Languages:
C/C++, Java, FORTRAN, Matlab, Perl.
Office Tools:
MS-OFFICE, Word, Excel, PowerPoint, FTP Tool.
PROFESSIONAL EXPERIENCE
Client Name, Location
 D
ate - Present
Statistical Programmer
Description:

Responsibilities:
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Ability to write some common macros that are useful across multiple studies.
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Ability to work on multiple projects simultaneously and meet the deadlines as and when
required.
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Performvalidation on derived datasets and following the standard operating procedures during
the validation process.
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Generate reports either in HTML, PDF or RTF formats according to the client specifications.
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Worked with Bio-statistician to analyze the results obtained from various statistical procedures
like PROC ANOVA, GLM and mixed models.
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Extensive use of PROC SQL to perform queries, join tables.
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Conducted analysis and generated tables, listings and graphs using SAS.
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Used data _null_ and PROC REPORT to generate the outputs.
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Involved in helping out the new programmers initially with the i3 standards and project setups.
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Ability to deliver theT L G ’s to the clients in the absence of the lead programmer and participating
in off-site meetings.
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Active participation in monthly departmental meetings and providing the necessary inputs on how
to improve the standards.
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Worked closely with Statisticians, Data managers.
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Extensive experience in working with people across other sites when required.
Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros, SAS/ Access, MS-Excel.
Client Name, Location
Date - Date
SAS Programmer/Analyst
Description :

Responsibilities:
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Involved in Phase II and III clinical trials by providing required tables and listings.
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Developed routine SAS Macros to create tables, graphs and listings for inclusion in clinical study
reports.
•
Worked on time to event data to generate the required results for the comparator drug and the
control drug.
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Reviewed large macro codes for running the programs.
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Worked on Kaplan-Meier macro to generate the graphs as per the requirements for FDA
submission.
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Validating the data sets and comparing the results to that of source programmers output.
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Timely submissions on the ACM requests.
Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros, SAS/Access, MS-Excel.
EDUCATION
M.S. in Biotechnology, Texas Tech University, USA