Statistical Programmer Resume Richmond, VA - Hire IT People

SUMMARY

Statistical Programmer with 5 years of experience supporting Statistical programming projects.
Experience in all phases (Phase I to III) of clinical trials: Analyzing clinical data, creating tables, listing and generating reports and graphs.
Proficient in SAS procedures like UNIVARIATE, PROC SQL, PROC SORT, PROC MIXED, PROCGPLOT, PROC GCHART, PROC DATASETS, PROC CONTENTS, PROC GLM, PROC FORMAT, etc.
Involved in Clinical Data Analysis and preparation of SAS Datasets, reports, tables, listings, summaries and graphs according to the Standard Operating Procedures (SOPs) and GCP guidelines.
Used procedures such as Freq, Means, Univariate, GLM, Mixed, Ttest, Npra1way, Report, and Transpose to prepare various satistical results in RTF formats
Experienced in producing Excel, RTF formatted files using SAS ODS to produce ad - hoc reports for presentation and further analysis.
Generated data definition tables, transportable files, ISS and ISE for NDA submission.
Expertise in coding, developing processes and documenting Import and Export of data across various platforms.
Manipulated and pool data from multiple studies quickly and accurately using methods such as Formats/Informats, Merge, Append, Sort, Transpose.
Experience with Base SAS, SAS/Macros, Proc SQL, SAS/STAT in the Windows and UNIX environment.
Generating Safety and Efficacy tables, data listings and graphs
Worked closely with Statisticians, Data managers and Medical writers
Good understanding of CRF Annotation, ICH, 21CFR part 11 guidelines, FDA regulations, WHO drug, MedDRA dictionaries

TECHNICAL SKILLS

SAS: SAS/BASE, SAS/MACROS, SAS/ACCESS, SAS/GRAPH, SAS/SQL, SAS/ODS,, SAS/STAT.

Operating systems: Windows 98/2000/XP/NT/7, MS-DOS, Sun Solaris-UNIX

Office tools: MS Office, Adobe Acrobat

PROFESSIONAL EXPERIENCE

Confidential, Richmond, VA

Statistical Programmer

Responsibilities:

Plan and coordinate programming, testing, and documentation of statistical programs for use in creating statistical tables, graphics
Used SAS Macros in analysis of standard clinical data and generated reports, graphs, listings, summaries and tables
Developed, maintained and utilized standard SAS naming conventions for macro library supporting consistency and reusability of programs
Used company defined macros extensively to standardize programs and make the code reusable
Maintained and updated existing utilities as per project requirements.
Involved in generating TLG’s for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.
Performed programming for internal and FDA ad hoc requests.
Created and validated Analysis datasets, Tables, Figures, and Listings according to the Statistical Analysis Plan (SAP)
Perform ADHOC programming per regulatory and statistician requests.

Confidential, Bridgewater, NJ

SAS Programmer

Responsibilities:

Plan and coordinate programming, testing, and documentation of statistical programs for use in creating statistical tables, graphics
Involved in e-submissions by creating Annotated CRFs, and Transport datasets in .XPT format
Developed Tables, Listings and Figures using PROC REPORT
Interacted with statistician and clinical people for creating reports
Experience in providing tables and figures to be incorporated into Clinical Study Report along with patient data listings and technical statistical details such as derivations, computations, analyses etc and also involved in discussions with medical writers in the preparation of Clinical Study Report
Formatted HTML, XML, ASCII, CSV, EXCEL, PDF and RTF reports, using SAS - Output Delivery System (ODS).
Interacted with other databases using SQL PASS THROUGH FACILITY.
Involved in coding analyzing, Report generation and testing programs using SAS/Base, SAS/Macro, SAS/Stat and SAS/SQL according to the client requirement
Performed quality controls (QC) on SAS programs.
Documented all project data flows and programs.
Responsible for implementing and monitoring clinical research trials, tracking study progress, and ensuring data integrity

Confidential

SAS Programmer

Responsibilities:

Involved in Phase I and Phase II clinical trials
Performed statistical analysis using SAS/Base, SAS Macro and other procedures like Proc freq, Proc Univariate and Proc Means.
Reviewed Protocol and Case Report Forms to identify irregular data entry errors of clinical trial data.
Created Safety and Efficacy customized reports for FDA regulatory submissions.
Effectively used many SAS functions like SCAN, SUBSTR, and TRIM.
Used Proc Import for importing data from Excel sheets and CSV files.
Applied PROC SQL, PROC FREQ and PROC MEANS for data analysis and generated report using PROC TABULATE and PROC REPORT.
Performed Ad-hoc Programming and Reporting.
Generated Analysis datasets, identified inconsistencies and problems in the database and reported the findings to the appropriate data management department personnel.

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Statistical Programmer Resume

Richmond, VA

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