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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 regulatorysubmissions.

Reporting computer validation inspections in compliance with 21 Code of Federal Regulations (21CFR, Part II).

Optimized performance using Data Validation and Data cleaning on Clinical Trial data usingStatistical 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 SKILLSSAS 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

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D

ate - 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.Performvalidation 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 procedureslike 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 theT L G 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 howto 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.Client Name, Location

Date - Date

SAS Programmer/Analyst

Description :

Responsibilities:Involved in Phase II and III clinical trials by providing required tables and listings.

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 thecontrol drug.

Reviewed large macro codes for running the programs.

Worked on Kaplan-Meier macro to generate the graphs as per the requirements for FDAsubmission.Validating the data sets and comparing the results to that of source programmers output.

Timely submissions on the ACM requests.Environment: SAS/Base, SAS/Stat, SAS/Graph, SAS/SQL, SAS/Macros, SAS/Access, MS-Excel.

EDUCATIONM.S. in Biotechnology, Texas Tech University, USA