PROFESSIONAL SUMMARY:

• Clinical SAS Programmer with 5 years of experience in different phases (I - IV) of clinical trials in Pharmaceutical, Health care and CRO industry.
• Worked on Various Therapeutic areas Like Central Nervous system, Diabetes, Oncology Cardiovascular System, at different levels of programming.
• Extensive experience in using SAS/BASE, SAS/MACROS, SAS/SQL, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/ACCESS and knowledge in statistical programming.
• Strong understanding of Study Design, Protocol, SAP, Data management Plan (DMP), Annotated CRF, Controlled Terminology, and raw datasets for all the studies assigned.
• Worked with Statisticians and Data managers to provide SAS programming in analyzing the trial data, generating reports, tables, listings and graphs.
• Extensive programming experience with different procedures like PROC PRINT, PROC CONTENTS, PROC COMPARE, PROC UNIVARIATE, PROC MEANS, PROC SUMMARY, PROC REPORT, PROC TABULATE, PROC FREQ, PROC REG, PROC TRANSPOSE, PROC GLM, PROC ANOVA, PROC TTEST, PROC LIFETEST, PROC MIXED and in appending, interleaving and merging SAS datasets.
• Used generalized linear models like ANOVA and ANCOVA for comparison of efficacy endpoints across treatment groups.
• Performed regression analysis of survival data based on Cox proportional hazard model using PROC PHREG.
• Handled Overall survival (OS) and Event-free survival (EFS) analysis based on Kaplan-Meier product limit estimates using PROC life test.
• Performed Progression free survival analysis (PFS) and time to event (TTE) analysis based on stratified log rank test and Kaplan-Meier product limit estimates.
• Working Experience in validating the SAS datasets using different SAS Procedures and writing Macros to Validate the SAS datasets and outputs.
• Experience in using SAS to read, write, import and export to another data file formats, including delimited files, Spreadsheets, Microsoft Excel and Oracle database.
• Created RTF, PDF and HTML listings, tables and reports using SAS ODS.
• Worked as DM programmer and worked on data cleaning, data archival, data migration, reporting and coding using SAS.
• Familiar with developing, administering validated systems and good understanding of 21 CFR Part 11 regulations, GCPs, ICH, and other regulatory guidelines including CDISCstandards for electronic submissions.
• Experienced in developing SDTM datasets from raw datasets using SAS and SDTM 3.1.2 and then later deriving the Analysis datasets following the given specifications.
• Worked with Statisticians to develop the SDTM specifications and Analysis dataset specifications.
• SAS/Testing on clinical trials projects as per requirements, understanding of data and testing the data to meet the specifications, working with clinical trial such as Demographics data, adverse event, Laboratory data, ECG data and Vital signs.
• Worked on Integrated summary of Safety/Efficacy. For Regulatory Submissions.
• Excellent organizational, teamwork, presentation, problem solving, decision making and interpersonal skills.
• Ability to learn new concepts fast and to carry out the assigned tasks with minimum supervision.
• Used Teamviewer to communicate with distant clients.
• Used Spotfire to present data.

SKILLS PROFILE:

OPERATING SYSTEMS: DOS, Windows 98/2000/XP, UNIX

DATABASES: MS Access, MS SQL server, Oracle

LANGUAGES: SAS, C, C++, SQL,PL/SQL

SAS TOOLS: SAS/Base, SAS/Stat, SAS/Graph, SAS/Access, SAS/Macro, SAS/Connect, SAS/SQL

FRONTEND TOOLS: MS Office 2000MS Word, Word Processing, MS Project, MS Excel, SQL tools

PROFESSIONAL EXPERIENCE:

Confidential, Waukegan, IL

SAS Clinical Programmer

Responsibilities:

• Generated statistical analysis tables, listings, and graphs to analyze the clinical trial data. For it primary and secondary end points.
• Created reports in the style format using ODS statements, PROC REPORT and PROC TEMPLATE, following the company standards and requirement to submit to FDA.
• Extensive interaction with the statisticians to understand the requirements on statistical methods and models.
• Worked with clinical data analysts in reviewing Case Report Form (CRF) to generate data summary and analysis reports.
• Created and validated analysis datasets, tables and listings and figures to support regulatory documents.
• Used SAS/STAT for descriptive statistics analysis like ANOVA, frequency distributions and to present results in histograms and box-plots.
• Used procedures like PRO FREQ, PROC MEANS, PROC SORT, PROC ANOVA, PROC REG, PROC GLM, PROC PRINT, PROC TABULATE and PROC REPORT to perform the statistical analysis.
• Worked with validation team to validate the applications compliance with 21 CFR part 11 regulations.
• Developed SAS programs for statistical analyses and data displays.
• Involved and worked in coordination with Statisticians to develop the mapping specifications for the development of SDTM datasets.
• Worked with various Versions MedDRA, getting the adverse event codes and in grading laboratory toxicity grading, WHO drug coding concomitant medications and medical history terms.

Environment: Base SAS, SAS Macros, SAS/Access, SAS/ASSIST, SAS/STAT, SAS/GRAPH, SAS/IML, ORACLE, SAS V9.1.3, SAS V9.2, Main Frames, Excel, Windows XP, UNIX.

Confidential, Canton, MI

SAS programmer/Analyst

Responsibilities:

• Created Analysis Datasets, Summary Tables, Listings and Plots according to the specifications of the study for statistical analysis.
• Extensively created TLGs for clinical trials from different clients encompassing several therapeutic areas according to the specifications provided by the biostatisticians.
• Created CDISC SDTM compliant datasets.
• Used ODS (output delivery system) extensively to generate reports in rtf and pdf format.
• Extensively worked on safety tables like SAE (serious adverse events), TEAE (treatment emergent adverse events), ECG, Lab shift, change from baseline lab tables etc.
• Understood and utilized company utility macros and tools for clinical trial reporting.
• Worked on Logistic regression analysis using PROC Logistic and PROC GLM.
• Experience working with MedDRA, WHO drug coding and lab data processing (lab normals, lab unit conversions etc.).
• Implemented LOCF (Last Observation Carried Forward), WOCF (Worst Observation Carried Forward) analysis for some longitudinal trials with missing data.
• Performed program documentation on all programs, files and variables for accurate historical record and for future .

Environment: SAS/BASE, SAS/SQL, SAS/ODS, SAS/STAT, SAS/MACROS, Excel.

Confidential, Zion, IL

SAS Programmer

Responsibilities:

• Developed close working relationships with other members of the Statistics team.
• Investigated missing data and data anomalies in SAS data sets.
• Involved in both clinical and statistical programming for Phase I clinical trial protocol.
• Generated tables, graphs, and listings for clinical study report for phase I.
• Review the protocol, case report forms (CRFs), statistical analysis plan (SAP) for Clinical trials.
• Data extraction from different sources, organizing data into SAS datasets.
• Extracted SAS datasets from SAS transport format files using PROC CIMPORT procedures.
• Involved with activities related to clinical data extraction, cleaning, querying, and providing reports to Clinical Data Associates, who coordinated the tasks of fixing inconsistencies in CRF data, by resolving the queries that they raised with sites.
• Responsible for doing analysis and load the data to the database for reporting.
• PROC SQL was used in coding concomitant medications data with WHO drug and medical history data was coded based on MedDRA.
• Developed and validated SAS programs to create TLG’s by using procedures like PROC REPORT, PROC TABULATE, PROC GPLOT, PROC FREQ and PROC UNIVARIATE.

Environment: Windows SAS. SAS/BASE, SAS/GRAPH, SAS/STAT, SAS/ACCESS, SAS/ODS, SAS/CONNECT