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CONSULTANT NAME
SUMMARY
• Certified SAS Programmer with over eight years of experience in Analysis, design, development,
testing and validating the applications.
• Strong knowledge involving all phases (I-IV) of clinical trials.
• Worked on SAS/Base, SAS/Stat, SAS/Access, SAS/Graphs and SAS/Macro.
• Expertise in analyzing and coordinating clinical trial data, generating reports, tables, listings and
graphs.
• Knowledge of CRF-Annotation with respect to various database designs.
• Knowledge of CRT Dataset creation from clinical trial data, CDISC and MedDRA for regulatory
submissions.
• Reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21
CFR, Part II).
• Optimized performance using Data Validation and Data cleaning on Clinical Trial data using
Statistical procedures like PROC FREQ, PROC MEANS, and PROC UNIVARIATE.
• Involved in writing and updating Standard operating procedures (SOP) for reviews and approvals.
• Experience in Ad-hoc programming for clinical and data management departments.
• Knowledge of Programming languages such as C and UNIX SHELL.
• Highly motivated individual with excellent organizational and interpersonal skills.
• Possess strong ability to quickly adapt to new applications and platforms.
• 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 Date - Present
Statistical Programmer
Description:
Responsibilities:
• Ability to write some common macros that are useful across multiple studies.
• Ability to work on multiple projects simultaneously and meet the deadlines as and when
required.
• Perform validation on derived datasets and following the standard operating procedures during
the validation process.
• Generate reports either in HTML, PDF or RTF formats according to the client specifications.
• Worked with Bio-statistician to analyze the results obtained from various statistical procedures
like PROC ANOVA, GLM and mixed models.
• Extensive use of PROC SQL to perform queries, join tables.
• Conducted analysis and generated tables, listings and graphs using SAS.
• Used data _null_ and PROC REPORT to generate the outputs.
• Involved in helping out the new programmers initially with the i3 standards and project setups.
• Ability to deliver the TLG’s to the clients in the absence of the lead programmer and participating
in off-site meetings.
• Active participation in monthly departmental meetings and providing the necessary inputs on how
to improve the standards.
• Worked closely with Statisticians, Data managers.
• 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.
EDUCATION
M.S. in Biotechnology, Texas Tech University, USA