PROFESSIONAL SUMMARY:

• Certified SAS programmer with 10+ years of experience in Statistical Analysis and 4 years of experience in Clinical Research /Pharmaceutical / Healthcare Industry with emphasis on data analysis using Excel, R, and SAS.
• A professional with expertise in statistics and extensive experience in clinical trials, Post - Marketing Pharmacovigilance Safety Risk Assessment using SAS, SQL, Spotfire and R as a statistician and data analyst.
• SAS BASE certified with the expertise of base SAS, SAS datasets, SAS functions, SAS programming, and SAS system reporting.
• Expertise in accessing data using SQL, advanced programming techniques, and macro processing execution of SAS macros
• Experience in creating outputs in different formats using SAS.
• Experience in generating Tables, Listings, and Graphs (TLGs) using SAS BASE, SAS MACRO, SAS/ODS, SAS/GRAPHS, and statistical analysis issues to elucidate efficient programming within defined timeframe.
• Experience in clinical trials programming in SAS with the knowledge of validating and reporting clinical trial data, and techniques suitable to the pharmaceutical industry.
• Created annotated CRF in both secondary data format and SDTM format and performed study specific Edit Checks.
• Derived Population Pharmacokinetics (POP PK) and Pharmacodynamics (PD) dataset for NONMEM analysis. Derived various NONMEM specific variables and other covariates for analysis.
• Knowledge of CDISC SDTM gapping/mapping/specs/conversion/domains/datasets, and specifications of analysis datasets
• Knowledge of common analysis involved in clinical trials including descriptive statistics, inferential statistics, time to event statistics to plan inferential testing, data modeling, linear statistical modeling, generalized linear model, logistic regression, categorical data analysis and survival analysis
• Firsthand experience with various CDMS platform including Oracle Clinical to organize the data of clinical trials
• Aptness in acquiring knowledge of new systems and function to build the strong technical environment. Proficient at project management to plan strategically, to utilize project resources adequately including time, people, and budget. Team player and self-starter with good communication skills and ability to work both independently and as part of a team.
• Extensive experience in publishing peer-reviewed scientific articles in national and international journals and presented the research work in both national and international academic conferences.
• Excellent understanding of SOP, protocol, ICH-GCP,21 CFR Part 11, and Clinical Data Interchange Standard Consortium (CDISC) guidelines to achieve ethical and scientific quality standards, and to generate, recreate, evaluate statistical analysis of clinical trials, submission, and documentation of data as per the CDISC standards.

WORK EXPERIENCE:

Confidential, Springfield, MO

Sr. Clinical Statistical Programmer

Responsibilities:

• Create new analysis dataset from the raw data received from the client
• Conduct qualitative analysis of the different biomarkers with interesting covariates
• Conduct statistical analysis on the analysis datasets using PROC NPAR1WAY, ANOVA, and REG.
• Involved in validating and QC of analysis datasets, listings and tables.
• Checking the normality of variable and calculating the Geometric Mean
• Computing the correlation between two variables.
• Compare two distributions using TTEST and compare more than two distributions using ANOVA
• Compare unbalanced distributions
• Examined the relationship between dependent and independent variables
• Involved in creation of Data Definition Tables (DDT) & SAS transport files (.xpt) for client submission.

Confidential, Somerset, NJ

Sr. Clinical SAS Programmer

Responsibilities:

• Created new analysis datasets from raw datasets for clinical trials based on the specifications in SDTM.
• Performed data analysis on the datasets using PROC MEANS, UNIVARIATE, TTEST, ANOVA, GLM, TRANSPOSE and PROC FREQ.
• Numerical variable descriptive statistics
• Checking the normality of variable and calculating the Geometric Mean
• Categorical variable descriptive statistics, Odds Ratio, Relative Risk, Chi-Square, Paired test, Kappa Coefficient
• Computing the correlation between two variables.
• Compare two distributions using TTEST and compare more than two distributions using ANOVA
• Compare unbalanced distributions
• Examined the relationship between dependent and independent variables
• Created and maintained production programs for tables and listings for final submission to FDA.
• Involved in validating and QC of analysis datasets, listings and tables.
• Involved in creation of Data Definition Tables (DDT) & SAS transport files (.xpt) for client submission.
• Prepared Analysis Datasets (ADaM) based on the standards of Analysis Data Model Implementation Guide ADaMIG Version 1.0.
• Performed queries, created and managed Tables, Indexes and In-Line Views, combined multiple tables using PROC SQL Inner join, Left, Right and Full Outer joins.
• Created new analysis datasets from raw datasets for clinical trials.
• Performed data analysis on the datasets using PROC MEANS, PROC UNIVARIATE and PROC FREQ, TTEST, ANOVA, GLM.
• Created and maintained production programs for tables and listings for final submission to FDA.
• Extensively involved in creating safety (AE, CM, DM, EX, LB, DS, VT, PE) and efficacy (PK data) tables, listings and figures.
• Involved in validating and QC of analysis datasets and tables.
• Developed NONMEM analysis data set. Derived various NONMEM specific variables.
• Involved in creation of Data Definition Tables (DDT) & SAS Export files (.xpt) for client submission.
• Produced Ad hoc reports of various kind, Listings, Tables, and Figures (TLGs/TLFs) using Proc report, proc tabulate, data null technique, proc, gplot etc.
• Involved in the creation of transport file (.xpt) including define.RTF/PDF for FDA submission.
• Customizing the existing macros according to the customer’s needs.
• Created analysis data dataset from raw data for AERS.
• Created and maintained programs for tables and listing as per the specification of FDA.
• Involved in validating and QC of tables, listings, and analysis dataset.
• Involved in creation of transport file (. XPT) for FDA submission.
• Conduct exploratory data analysis using Spotfire.

Confidential, San Marcos, TX

Adjunct Faculty

Responsibilities:

• Teaching Computer applications in Agriculture.
• Teaching undergraduate level students basics of statistical software like SAS and R and Microsoft Office Applications such as WORD, EXCEL, ACCESS, and PowerPoint.

Confidential, Kingston, RI

Research Assistant

Responsibilities:

• Worked as research assistant in Department of Computer Science and Statistics and Department of Environment and Natural Resource Economics.
• Actively involved in data analysis using primary and secondary data.
• Performed various analysis using
• Mixed-effect models within a Hedonic Price Model
• Discrete dependent variable models such as Multinomial Model, Conditional Multinomial models,
• Non-linear models such as Almost Ideal Demand System, and
• Developed bio economic models based on the variables affecting the variable of interest.
• Created macros in statistical software STATA.
• Created graphs and geographical calculations using R.
• Primarily involved in writing research grant proposal from Federal Government Agency.

Confidential, Pine Bluff, AR

Research Assistant

Responsibilities:

• Actively involved in production economic studies.
• Performed ANOVA, regression analysis using JMP.