CONSULTANT NAME
(SAS Developer)
SUMMARY
| 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.
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| Databases: | Oracle Clinical, Clin-Trial, SQL server, Oracle7x/8x.
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| Operating Systems: | UNIX, Linux, Windows98/2000/NT/XP.
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| Languages: | C/C++, Java, FORTRAN, Matlab, Perl.
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| Office Tools: | MS-OFFICE, Word, Excel, PowerPoint, FTP Tool. |
PROFESSIONAL EXPERIENCE
| Client Name |
From Date - To Date |
| Statistical Programmer | |
Project: Project Name
Description:
Responsibilities:
| 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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| Perform validation 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 the TLG’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 |
From Date - To Date |
| SAS Programmer/Analyst | |
Project: Project Name
Description:
Responsibilities:
| 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.
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| 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/CERTIFICATIONS/AWARDS
M.S. in Biotechnology from Texas Tech University, USA
SAS Certified Base Programmer V9
PLEASE YOUR COMMENTS BELOW
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