Data Project

SCIENTIST, BIOSTATISTICS

As a highly competent statistician and scientist, I have demonstrated my ability to identify complex problems and review related information to develop and evaluate options in order to implement and present solutions. I demonstrated excellent verbal and written communication skills when fostering strong working relations with statisticians and non-statisticians. This enables me to work well on multiple projects both individually and in a team with minimal supervision. I possess working knowledge of statistical software such as SAS, Minitab and R. Advanced knowledge of study design, power calculations, sample size determination, data collection, working out appropriate statistical methods, descriptive and abstract statistics, graphical analysis, poster and manuscript development enable me to take a lead role as a Biostatistician III at Dendreon. I have advanced knowledge of statistical data analysis include ANOVA, ANCOVA, discrete and continuous distributions. Additionally, my superb understanding of statistical approaches used in results processing allows me to accomplish scientific projects with efficiently. I also have experience in working with the FDA.

EDUCATION & CREDENTIALS

Master of Science, Biostatistics

NEW JERSEY INSTITUTE OF TECHNOLOGY 2011

Dean’s List

Bachelor of Science, Biotechnology

RUTGERS UNIVERSITY 2009

Dean’s List, Best Academic performance in the Biology and Statistics Department

AREAS OF EXPERTISE

MSWord & Excel

PowerPoint

C++

R

JAVA

Minitab

SAS

LabWare LIMS

PROFESSIONAL EXPERIENCE

DENDREON Morris Plain 2010 - Present

Biostatistician-III 2011 - Present

• Analyzed and interpreted all project protocols, wrote protocols, and created study randomization

• Interfaced with researchers to provide statistical support in terms of statistical design and analysis, database creation, and creation of formatted statistical analyses tables and summaries

• Involved in all phases of data collection and processing to insure the integrity and validity of the data analysis

• Sample Size and Power Calculation for an Ongoing Phase III Bladder Cancer Trial

• Review and acquired knowledge about documents related clinical trials like clinical protocol, SAP, Clinical Study Report and aCRF (Annotated CRF)

• Maintenance of large data sets, combining data from various sources in varying formats to create SAS data sets.

• Developed listings, tables and graphs for efficacy and safety of clinical studies

• Used Dynamic Data Exchange feature of SAS for importing and exporting of data from and into SAS and Excel

• Developed SAS programs for data cleaning and validation

• Participated in meetings with FDA and conducted communications with FDA statisticians

• Presented project updates as scientific presentations to department heads on a regular basis

• Consistent record of achievement in project management, dramatically improving software operating stability, efficiency, and profitability

• Streamlined, optimized, and improved software and system functionality, efficiency, operational stability, and recoverability in mission-critical environments

• Performed and improved Data analysis procedures of raw data by cleaning up imperfect data sets to help researchers extract conclusions. Wrote reports compiling raw data into usable material

• Engaged in the development and implementation of SOPs within the organization

• Evaluated current processes and suggested improvements based on the results of research studies within the organization.

• Provided support and mentoring to other statisticians within the department

Biostatistician-II, 2010 - 2011

• Earned promotion to Biostatistician II level and presented with Best Analyst Award in 2011

• Created new analysis datasets from raw datasets for clinical trials

• Created reusable Macros and developed SAS Programs for Data Cleaning, Validation and Analysis and Report generation

• SAS programming: Performed data analysis on the datasets using PROC UNIVARIATE, PROC MEANS, PROC FREQ, and PROC ANOVA

• Performed Quality Checks on the existing table, listing and figures

• Analyzed and examined complex data and evaluated the statistical methods and procedures used to obtain data in order to ensure validity, applicability, efficiency, and accuracy

• Hands on Experience in developing mock-up tables referring CRF, SAP

• Attended project team meetings, worked with Data Managers and Clinical Research Managers as appropriate. Reviewed and provided feedback for Data Integrity Plans.

• Processed large amounts of data for statistical modeling and graphic analysis, using the LIMS software

• Reported results of the statistical analyses in the form of graphs, charts, and tables using superb documentation practices to ensure data integrity and traceability

• Designed impeccable and user-friendly worksheets, table formats, and charts and supervised their presentation

MERCK & CO. INC. Rahway 2009

Biostatistician-I

• Involved in study design, planning of statistical methods, the data collection and management, the analysis of trial results, and writing of clinical study reports.

• SAS programming: Performed data analysis on the datasets using PROC UNIVARIATE, PROC MEANS, PROC FREQ, and PROC ANOVA

• Data Management: Data Collection, Data Entry, Data Cleaning, Data Security

• Data analysis: Developed statistical plan, analyzing data using SAS, R and Minitab

CHURCH & DWIGHT Princeton 2008

Scientist-I

• Devised efficient and streamlined processes to conduct data analysis

• HPLC and UV operating experience in research, which includes purification and analysis programming design, data processing, instrument study, and method optimizing

• Engaged in the development and implementation of SOPs within the organization

• Administered routine maintenance of instrumentations

BASF THE CHEMICAL COMPANY Iselin 2007

Associate Scientist

• Utilize analytical techniques and instrumentation, such as gas and high performance liquid chromatography (HPLC), ion chromatography, electro chromatography and spectroscopy

• Maintained and generated computer database of chemicals used in company

• Helped to write comprehensive and all-encompassing SOPs

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