Biostatistician

SUMMARY OF QUALIFICATIONS

Prepare statistical and programming activities for pre-clinical, Phase 1 and 2, 3 and/or Phase 4 clinical trials and epidemiologic studies.

Work with different clinical trial/studies therapeutic areas as Infections and Infectious Diseases, Oncology, Obstetrics/Gynecology, Nutrition and Weight Loss, Cardiology/Vascular Diseases Pediatrics/neonatology, and Pulmonary/Respiratory Diseases.

Develop, maintain, and produce statistical analysis programs and specifications used in creating data sets, tables, listings and charts based on clinical or other medical research protocols, and statistical methodology.

Analyze large clinical data using statistical approaches such as longitudinal analysis, mixed effect modeling, logistic regression analyses, and model building techniques.

Works closely with clinicians and Study Statistician to write Statistical Analysis Plans (SAP) and to prepare mockup tables, listings, and graphs.

Draw conclusions or make predictions based on data summaries or statistical analyses

Works closely with SAS programmers and Study Statistician to create SDTM and ADaM specifications and datasets.

Prepare statistical data for inclusion in reports to data monitoring committees, federal regulatory agencies, managers.

Advanced programming level with statistical software packages such as SAS, SPSS, and Minitab.

EDUCATION

2009

1995

CALIFORNIA STATE UNIVERSITY EAST BAY/ Department of statistics & Biostatistics, Hayward, CA. M.S. Degree.

Major: M.S. Degree in Statistics. Class Dec/2009.

Option: Applied biostatistics.

CAIRO UNIVERSITY / Faculty of Economic & Political Science, Cairo, Egypt. B.S. Degree. Class May/1995

Major: Statistics

COMPUTER SKILLS

Proficiency in SAS functions, procedure SQL, and Unix

Proficiency in Minitab, SPSS, Excel, and Comfortable with R code.

Proficiency in PC operation (MS Windows, Microsoft Word, Power Point, Excel Application, and Visio).

PROFESSIONAL MEMBERSHIP

American Statistical Association.

EXPERIENCE

Jun 2014- Jan 2015

CLINICAL STATISTICIAN II

AbbVie- GPRD-Global Pharmaceutical R&D, North Chicago, IL

Work at Data and Statistical Sciences (DSS) Organization team:

Contribute to decision making on study design and data collection, and with supervision, ensure appropriateness to support study objectives. Responsible for randomization specifications and sample size calculations for routine studies and with supervisor guidance, for non-routine studies.

When appropriate, author first draft (routine studies) or contribute to (non-routine studies) of statistical methods, and ensure statistical methods adequately address study objectives.

Ensure clarity, accuracy and consistency of CRFs, database definitions, and specifications for analysis data sets for individual studies. Review for consistency across studies within a project. Assist development of project conventions and verify project conventions are followed. Ensure accuracy of database quality assurance checks and assess data accuracy and consistency. Develop database checks for routine situations.

Demonstrate the ability to apply statistical knowledge to solve drug development problems. Develop SAPs for routine and, with supervision, non-routine studies.

With appropriate level of supervision, provide timely and accurate statistical analyses. Identify and report on data issues or violation of statistical assumptions that could affect the validity or sensitivity of planned analyses and recommend alternative analysis strategies.

Ensure accuracy and internal consistency of report or publication, including text, analyses, tables, listings, and figures.

Identify and recommend corrections for flaws in scientific logic and statistical interpretation. Ensure consistency in presentation, inference, and adherence to accepted report guidelines and publication practices.

Sep2012- Aug2013

ASSOCIATE STATISTICIAN

InClin.Inc, San Mateo, CA

Assists Statisticians I and II on statistical and programming activities for pre-clinical, Phase 1 and 2, 3 and/or Phase 4 clinical trials and epidemiologic studies. Specific responsibilities include:

Collaborate with Data Management and review Case Report Forms, completion guidelines, edit check specifications, and data transfer specifications.

Write a draft Statistical Analysis Plans (SAPs) and develop mock tables and listings for Phase 1 and 2 clinical trials. Collaborate with senior Statisticians on incorporating appropriate statistical methodology in SAPs and developing analysis plans for Phase 3 and 4 clinical trials.

Work with the SAS programmers on development of analysis database specifications and programming of tables, listings and figures.

Complete program validation and quality control (QC) of tables, listings and figures (TFLs) produced by the SAS programmers for Phase 1 and 2 trials. Collaborate with senior Statisticians on review and QC of TFLs for Phase 3 and 4 clinical trials.

Review dummy randomization schedules developed by senior Statisticians and review implementation procedures.

Contribute to project documentation and ensure adherence to Standard Operating Procedures for statistical activities.

Work with senior Statisticians on ad hoc analyses of new and completed studies, including analyses for manuscript preparation.

Participate in internal study team meetings.

Nov2010 to Apr2011

STATISTICAL RESEARCH ANALYST II

The Center of Health Research( CHR) at Kaiser Permanente (KP),Portland, OR

Assist and collaborate with CHR investigators (senior biostatisticians) in conducting research by providing high level technical and statistical expertise and support in data collection, management, analysis, interpretation, and reporting.

Two projects:

1.Promoting Adherence to Improve Effectiveness of Cardiovascular Disease Therapies PATIENT. Phase III

2.Weight Loss Maintenance Trial Coordinating Center WLM. Phase II

Process large amounts of data for statistical modeling and graphic analysis, using SAS programming.

Report results of statistical analyses, including information in the form of graphs, charts, and tables.

Write SAS programs to create analysis data sets and to conduct ongoing trial monitoring according to inclusion and exclusion criteria in the study protocol.

Evaluate the statistical methods and procedures used to obtain data to ensure validity, applicability, efficiency, and accuracy

Carry out data cleaning activities as needed.

Assist in the preparation of materials for use in study reports, research manuscripts, and audiovisual presentation of study data.

Maintain records for all assigned deliverable, including tracking of analysis deliverable, archiving of trial analysis and associated documentation according to departmental guidelines.

Provide input as required at all meetings, discussions and activities covering aspects of statistical reporting on study activities.

Read current literature, attend meetings or conferences, and talk with colleagues to keep abreast of methodological or conceptual developments in fields such as biostatistics, pharmacology, life sciences, and social sciences.

Sep 2009 to Dec 2009

EPIDEMIOLOGIST- INTERNSHIP

San Mateo County Health System, San Mateo, CA

Write computer programs by using SAS and MINITAB to create analysis data sets, reports, tables, graphs, and charts.

Performed statistics analysis of salmonella data and interpret the effect for the medicine and disease through the descriptive statistics, correlation and Chi square test.

Provide data cleaning work by using SAS procedures and Box plot.

Jan 2008 – Dec 2009

GRADUATE ASSISTANT

Department of statistics & Biostatistics - CSUEB, Hayward, CA

GRADUATE PROJECT ASSISTANT

Three projects

Performed statistical analysis of data: Interpretation of Quality-of-Life Outcomes.

Applied statistical analysis of data: By using R code.

Applied statistical analysis of data: By using SAS code.

GRADUATE TEACHING ASSISTANT

STAT1000 Elements of Probability and Statistics

Descriptive statistics (measures of central tendency, dispersion, correlation),

Elementary discrete probability distributions.

Introduction to tests of statistical hypotheses.

Grade the students' homework and Exams

ADDITIONAL SKILLS:

Oct 2006 to Sep 2010

ASSISTANT MANAGER

Walgreens.Inc, San Francisco, CA

Assisting the Store Manager in the operation of the store and in the direction of the work force.

Direct, coordinate, and manage the activities, plans and programs of the immediate staff within the guidelines of authorized Company policies, budgets, laws, and good business ethics.

Improving unit sales, profits and image through the overall development and protection of store.

Assist in the training and development of store personnel, and the proper service to all customers.

Manage inventory budgets, select and order new merchandise, liquidate overstocked items.

Assist in recommending policies designed to maximize profits.

Assist in facilitating the implementation of any new technology.

Assist the Pharmacy Manager toward success of the operation.

Maintain the superior customer service policies.

Maintain awareness of the competition as well as developments in the retail industry and management field.

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