SUMMARY

• Having 7+ years of experience in SAS programming and experience in analysis, design, development, testing and implementation of Clinical Trial Projects in Pharmaceutical industries & CRO’s.
• Thorough knowledge of Clinical Trials data like Demographic data, Vital Signs, Adverse Events (AE), PKPD data, ECG, Laboratory data and other Safety and Efficacy related data.
• Generating Safety and Efficacy tables, data listings and graphs.
• Knowledge in creating datasets and table programming for ISE (Integrated Summary of Efficacy) and ISS (Integrated Summary of Safety) submissions to the FDA and EMEA.
• Pooled data from multiple studies and created a comprehensive data pool.
• Integrated data from different sources incoming from different vendors (e.g., SAS datasets from different CRO’s, electronic laboratory data).
• Extensive use of the proc transpose, proc univariate, proc summary, proc means, proc freq, proc tabulate, proc contents, proc sort, proc print, proc glm, proc sql, proc gplot and proc gchart
• Advanced experience includes using Base Procedures, Graph, Macro programs and macro variables, Data Step, SQL, Access to Oracle, DB2, SQL Server, and PC files, Output Delivery System (ODS).
• Performed Cleaning Techniques, QC Validation and Edit Checks as per protocol designs on Clinical Data.
• Extensive experience with Base SAS, SAS/Macros, Proc SQL, SAS/STAT in the Windows and UNIX environment.
• Familiarity with ICH, GCP guidelines and Electronic Submission standards.
• Knowledge of industry practices with CDISC standards, SDTM and ADaM.
• Worked closely with Statisticians, Data managers and Medical writers
• Demonstrated ability to work collaboratively in a team environment as well as independently.

TECHNICAL SKILLS

Statistical Software: SAS v 6.12/7.1/8.0/9.1 , SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACRO, SAS/GRAPH, SAS/ACCESS, SAS/CONNECT, SAS/ODS, Enterprise Guide.

Database: MS Access, Oracle clinical

Operating Systems: Windows 9x/2000, XP, NT, UNIX.

Software: OPENCDISC, MS Word, MS Excel, Excel VBA, MS Access, MS Project, MS PowerPoint.

PROFESSIONAL EXPERIENCE

Confidential, Ann Arbor, MI

Sr. Statistical Programmer

Responsibilities:

• Created and validated ADaM datasets for safety and efficacy datasets.
• Checked the compliance of sdtms using OPENCDISC tool.
• Developed dynamic SAS programs using SAS BASE, STATS & GRAPHS.
• Developed analysis datasets and produced tables, listings, and graphs.
• Handled adhoc requests from FDA and EMEA agencies.
• Created edit check programs to perform quality check on the OC data.
• Involved in QC of CDISC SDTM data sets and developed macros for validation process
• Extensively involved in SAS SQL programming to modify the QC, development and FDA reporting programs to access the new database created as a part of knowledge base integration project.
• Created reports in the style format using ODS statements and PROC TEMPLATE.
• SAS MACROS were used extensively in analysis of standard clinical data and generated reports, graphs, listings, summaries and tables.
• Analyzed and cleaned the data sets using Data Null, PROC FREQ, PROC MEANS, and PROC UNIVARIATE.
• Used PROC SORT, SET, UPDATE AND MERGE statements for creating, updating and merging various SAS datasets
• Involved with the QC and Validation of tables listings and graphs.

Environment: SAS 9.1 (Base, Macros, SQL, Proc), SAS/Graph, SAS/Connect, SAS/Access, SAS/STAT, Excel, PL/SQL, Oracle 10g, UNIX

Confidential, NUTLEY, NJ

Sr. Statistical Programmer

Responsibilities:

• Developed, maintained and utilized standard SAS naming conventions for macro library supporting consistency and reusability of programs.
• Extensive experience in Creating and Extracting Oracle tables from SAS and within Oracle by using SAS/Access, SAS/SQL
• Developing SAS code according to the design specifications and Produced tables, listings and graphs for FDA study submissions.
• Customized reports using PROC TABULATE, REPORT, SUMMARY and also provided descriptive statistics using Proc Means, Frequency, and Univariate
• Performed statistical analysis with SAS/STAT, including PROC T - TEST, PROC GLM, PROC ANOVA, PROC REG, PROC CORR
• Used PROC GCHART, PROC GPLOT to generate graphs.
• Programmed edit checks to satisfy data collection standards, storage, and analysis for clinical studies.
• Involved in validating and QC of the efficacy, safety tables and listings

Environment: SAS 9.1 (Base, Macros, SQL, Proc), SAS/STAT, SAS/Graph, SAS/Access, SQL, Excel, Oracle, UNIX, Windows XP/2000/NT.

Confidential, Jersey city, NJ

SAS Developer

Responsibilities:

• Responsible for carrying out development of Clinical data review listings in SAS and COGNOS.
• Responsible for writing and generalizing macros for data extraction and for other standard tasks.
• Responsible for developing Edit check programs in SAS.
• Responsible for developing External data reconciliation programs, CRF listing programs and also LAB listing programs.
• Responsible for the development of the SAS code for the study and develop SAS reports for all the above.
• Responsible for the development of interactive GUI using SAS/AF
• Module designing, Documentation, Coding, Debugging, Preparation of Unit Test plans, Unit testing, Self-Reviews and Bug Fixing.
• Responsible for preparing test plans and test cases for the SAS code developed.

Environment: Clinctrial, PC SAS 9.1, SQL, Windows NT.

Confidential

SAS Analyst

Responsibilities:

• Extracted data from Excel sheet using Proc Import.
• Created SAS datasets like Demographics, Adverse Events, Labs, Vital signs.
• Created datasets and modified existing datasets using Set, Merge, Sort and Proc Sql with various SAS functions.
• Validated SAS data sets using SAS procedures like Proc Means, Proc Freq and Proc Univariate.
• Prepared tables, listings and graphs as per Statistical Analysis Plan.
• Generated Plots and Charts according to the requirements.
• Used ODS (Output Delivery System) to display output in HTML, PDF, and RTF formats.

Environment: SAS/BASE, SAS/MACROS, SAS/GRAPH, SAS/STAT, WINDOWS NT.