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 Expert  726392

Expert in Biostatistics Phase I, II trials, Translational research; Design, Analysis, Presentation


Available for your Consulting and Expert Witness Needs

ON
Canada
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise:

Listed with other top experts in: 

MD and MS in biostatistics with more than ten years of relevant professional, supervision and management experience

• Experience in providing support to biomedical researchers regarding statistical aspects of study design • Expert in statistical techniques used in analysis of clinical trials and reporting (Phase I/II/III/IV) • Responsible for statistical work on several successful US and Canadian clinical trials. • Substantial work experience of liaison with regulatory authorities. • Statistical computing proficiency with standard statistical software: SAS, JMP, STATA, HLM. • Data management experience in design CRFs, data entry and database systems, data cleaning. • Proficiency in scientific writing; effective communicator of scientific and/or clinical data

•Oversee and manage all operational aspects of the local investigator-initiated clinical studies. •Serve as a lead statistician on clinical studies. •Maintain the statistical and analytical integrity of clinical trials. •Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. •Support study development and project management with strategic planning, proposals, pricing, and timeline planning.

THERAPEUTIC AREAS • Oncology • Cardiovascular: drugs and devices

EDUCATION & CERTIFICATION

2008 - PhD candidate - University of Medicine and Pharmacy, Timisoara, RO 2004 - Master of Science, Biostatistics - Columbia University - Mailman School of Public Health, NY 1991 - Doctor of Medicine - University of Medicine and Pharmacy, Timisoara, RO

2008 - Certified in Public Health - National Board of Public Health Examiners

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antineoplastic protocol

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applied statistics

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biological response

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biostatistics

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bivariate analysis

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chi-square method

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clinical protocol

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clinical trial

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continuous distribution function

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data correlation

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discriminant analysis

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factor analysis

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histogram

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Kolmogorov-Smirnov test

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medical statistics

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metastasis

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mutagenesis

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oncogenesis

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pathologic process

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pharmacoepidemiology

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reproductive epidemiology

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sampling plan

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skewed density function

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statistic

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statistical data analysis

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statistical design of experiments

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statistical inference

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statistical median

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statistical method

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statistics


Show Secondary and Basic Areas of Expertise

Education:
Year   Degree   Subject   Institution  
1991   MD   Medicine   University of Medicine and Pharmacy, Timisoara  
2004   MS   Biostatistics   Columbia University - Mailman School of Public Health, NY  

Work History:
Years   Employer   Title   Responsibilities

2005 to

 

(Undisclosed)

 

Clinical Research Scientist

 

He provides scientific, analitic and methodological support for investigators from academia on design, statistical analysis and reporting of clinical trials, integrated summaries; liaison with regulatory authorities; statistical programming; publications in phase I, II clinical trials and translational research

2004 to 2005

 

The University of Texas School of Public Health at Houston US

 

Biostatistician

 

He was responsible for data analysis, presentation and scientific writing for the statistics section of the manuscripts of The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).

2000 to 2004

 

Cardiovascular Research Foundation - NY US

 

Research Fellow

 

He worked as research fellow, on phase II and III trials, in interventional cardiology

1994 to 1999

 

APIC International Romania

 

Medical Science Liaison

 

He provided scientific support to opinion leaders, community physicians, investigators and other healthcare providers and methodological support to investigator's requests for investigator-initiated studies

1993 to 1994

 

Private Practitioner

 

Family Medicine

 

He provided primary care devoted to comprehensive health care to people of all ages.


Career Accomplishments:
Associations/Societies

Romanian Medical Association (AMR), American Statistical Association (ASA), Canadian Society for Epidemiology and Biostatistics (CSEB), European Society for Medical Oncology (ESMO), American Society of Clinical Oncology (ASCO), Society for Clinical Trials (SCT) ,

Licenses/Certifications

CPH - Certified in Public Health - National Board of Public Health Examiners


Publications:
Publications and Patents Summary

He has 3 research grants, 2 peer-reviewed articles, 6 non peer-reviewed articles, more than 25 posters and abstracts


Consulting Services:
Recent Client Requests:
  • Investigator initiated study expert.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region  
2000 to 2005   United States  
1993 to 1999   Romania - Europe  

Language Skills:
Foreign Language   Description
Romanian   His native language

Additional Skills and Services:
Other Skills and Services

He provided occasional ad-hoc consulting on design and analysis of clinical trials in an academic environment.


 

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