SUMMARY OF EXPERIENCE

• Certified SAS Programmer with over 4 yrs and CRO experience. Experience includes Clinical Research and Analysis,
• Design, development, testing and implementation of Clinical Trial projects in Pharmaceutical.
• Created programs for phase’s I-IV of clinical trials as per FDA Submission regulationsusingICH and GCP guidelines, CDISC v3.1.1 SDTM implementation, 21 Code of Federal Regulation (Part 11), NDA and IND applications.
• Extensively worked in Phase I (Pharmacokinetic & Pharmacodynamic) for various crossover and general clinical trial studies. Created NCA files for PK parameter analysis assigned by PK scientist.
• Created SOP’s (Standard Operating Procedures) and SAP (Statistical Analysis Plan).
• Experienced working with various kinds of Clinical Trials data like Demographic data, Substance Use data, Adverse Events, Protocol Deviation, Laboratoryand various other study related domains.

• Created SAS Macros forISO 8601 isodate, creating SASINIT environment to create the entire data library. Also created data extraction program to extract data from Oracle Client.
• Experienced working with Oracle Client and ClinTrial data server’s for the extraction of data and creating transport files.
• Created Adhoc Figures and Tables for various crossover studies.

• Worked on CDISC 3.1.1,and3.1.2 version to create SDTM domains and specification. Worked on process for creation of Define.xml.

• Used base SAS procedures like PROCFREQ, SQL, SORT, TABULATE, MEANS etc; to validate current results with expected results. Knowledge in preparing Integrated Summaries of Efficacy (ISE) and Safety (ISS) reports.
• Generation of SAS listing and tables into PDF, RTF and HTML formats to meet specifications by using SAS ODS.
• Certified Base Programmer for SAS 9.

TECHNICAL SKILLS

•  SAS Tools: SAS 6/7/8, SAS/MACROS, SAS Enterprise Guide, SAS/SQL, ANOVA, SAS Viewer, Ultra Edit
•  Languages: C, PL/SQL, SQL, Visual Basic, HTML
•  Database: Oracle, SQL Server 2000, MS Access, DB2
•  Operating Systems: Windows 95, Windows 2000, Windows NT, MS DOS, UNIX

EXPERIENCE

SAS Programmer Analyst I, Confidential July, 09 – Present

Confidential, Ellicott City, MD

• Extensively worked in Phase I (Pharmacokinetic and Pharmacodynamic) for various crossover and general studies.
• Extensively worked in creating Graphs Tables and Listings for various therapeutic areas.
• Created PK Tables and Listings for PK and PD parameters for statistical analysis based on specifications.
• Extensively created graphs such as Mean & Standard Error plots, Scatter plots, Waterfall plots, Spaghetti plotsand Overlay plots for various Phase 1 studies, important to make the decision for statistical analysis for the drug.
• Created NCA files for PK parameter and Concentration data for analysis as per specifications from PK scientist.
• Created Adhoc Tables and Listings for various therapeutic areas.
• Created Listings and Figures to a design the study on the basis of Statistical analysis.
• Worked with Data Management for creating Edit Check programs during the study lock procedure.
• Written macro program for data extraction from Oracle Client.
• Adopted the double programming method to perform QC on tables and listings to improve the quality of the output.

SAS Programmer, Clinical Research August, 08 – May,09

Confidential, Bloomingdale, IL

• Created various SDTM domain as per SDTM 3.1.1 and 3.1.2 version and also the domain Specs.
• Created custom designed domain for various aspect of Oncology and Pain study for both Phase II and Phase II – Phase IIIstudies respectively.
• Created various SDTM domains such as Vitals, Demographics, Labs, Questionnaires, Adverse Event.
• Review and creation of ADaM & SDTM domain specifications according to SDTM 3.1.1 & 3.1.2 version.
• Created Tables, Listings and graphs according to specifications also created ADaMdataset for both Oncology and Pain analgesic studies.
• Testing and debugging Define.xml for quality and standards followed according to the SDTM implementation guide, performing check for all active hyperlinks and CRF’s.
• Created different metadata for final creation of define.xml like Value level, Variable value level, ControlledTerminology, Table of contents, Schema, Data level Metadata and final creation of Define.xmldocument.
• Successfully created the code for Define.xml to make an easy process to create Define.xml.
• Created Annotated CRF’s as per FDA Submission regulations.

Statistical Programmer December, 07- August,08

Confidential, Buffalo Grove, IL

RESPONSIBILITIES:

• Proficient in data analysis, statistical analysis, generated reports, listings and graphs using SAS TOOLS –

SAS/ Base, SAS/Macros, SAS/Graphs, SAS/SQL and SAS/Connect.

• Producing table, listings, figures & validating different methods like FIP (Full Individual Program)

and FIPS (Full Individual Program & Spot Checking),Visual Review, CODE REVIEW,SPOT CHECKING.

• Generated ADaM datasets according to the specifications provided by the statistician and CDISC standards.
• Reviewing analysis plans including specifications for tables listings. Taking raw data and creating analysis datasets.

Used SAS for pre-processing data, data analysis, generating reports, and statistical analyses.

• Creating permanent formatted SAS data sets and developed reports using PROC REPORT, PROC TABULATE and DATA_NULL_ to make global variables & reporting summary table for analysis. WroteEdit check programs and listings of data.
• Generated P-value using various methods as PROC ANOVA, PROC MLR and PROC GLM, PROC REG Studies.
• Created SAS transport files for electronic submission using PROC COPY & PROC CIMPORT.

• Testing and debugging against the test data and Ascertaining quality and standards for the code changes made. Responsible for locating appropriate databases for projects.

Graduate Research Assistant September 2006 –December2007

Confidential, Arlington, TX

• Responsibilities for Calibration of various graphical user interfaces such as Noise Audio Dosimeter, GlovePressureMapping system, DataLOG and to analyzetheir data using SAS and various statistical procedures.

• Responsibility of analysis of data obtained using all user interface and to validate that data using SAS analysis and various statistical tools such as ANOVA, SLR, MLR, Correlation & Regression.
• Worked in collaboration with Kinesiology Department, University of Texas at Arlington, while working on the Designing of the Workstation Lifting Techniques using Force Plate Technique & Vicon Motion System.

• Performed the analysis of obtained data using anthropometry analysis and performed various statistical analysis

Using various tests such as t-test, f-test, and obtained p values to check the data significance and also to check for the outliers.

• Worked on the various aspects of Ergonomics following standard specification of NASA, OSHA, and NIOSHand perform Statistical evaluation of the data obtained.

• Attended several conferences on Human Factors & Ergonomics as Student representative of University.

Simple Linear Regression Analysis for Relation between Muscle Strength and Lean Body Mass:

• The aim of this project is to establish relationship between muscle strength and lean body mass of more than 20 individuals and to estimate dependent variable muscle strength and independent variable lean body mass.
• Relationship between dependent and independent variable is estimated with the use of Pearson’s correlation coefficient, through which we created linear regression equation and then we predicted the value of one measurement from the knowledge of the other variable.
• We have also calculated the variance and coefficient of determination (R-square) to evaluate the variation between dependent and independent variable and to estimate the relation between muscle strength and lean body mass.
• We also evaluated the ANOVA using F-test to predict about independence, normality and homogeneity of data. Also performed the Modified Levene Test using SAS in terms to compare the datasets,expecting if normality is not present.
• Outcome of the project was relationship betweendependent and independent variable was positive with all data points lying in the same line.

Multiple Linear Regression Analysis for relation between the Avg. MPG and the Number of Cylinders, Engine size, Horsepower, RPM, Engine Revolution per Mile, and the Weight of cars sold in 1993:

• The aim of the project was to analyze the general factor that affect the fuel economy of the car. Based on the data available we selected 4 predictor variables Number of cylinders, Engine size, RPM and Weight.
• In this we created the regression line using response variable (Average) vs 4 predictor variables to fit the data into regression model. In this we perform model adequacy analysis to see the relationship between predictor variables
• To plot the curvature of the predictor variable, we used PROC GPLOT. In the dataset obtained we consider two situations one being normality OK, and another being non-OK and we performed both Bresuh-Pagan Test and Modified Levene Test.
• Performed the Normality testto confirm the outliers and BonFerroni Outlier test.
• Performed the Influence analysis test to check the influence of single fitted valueand influence on individual least square estimators.
• Conducted Variance Inflation factor to see the rise in multi-collinearity.
• Performed Backward Deletion method, best subset method, and Stepwise regression method by keeping condition of best model with Higher (R),Lower MSE and Lower Cp.

EDUCATION

Industrial Engineering,Master of Science
Instrumentation Engineering, Bachelor of Technology 

• SAS/BASE, SAS/MACRO
• SAS/STAT
• SAS/GRAPH, SAS Enterprise Guide, SAS/SQL SAS/Access SASViewer UltraEdit