Expert Details
Biostatistics Phase I, II trials, Translational research; Design, Analysis, Presentation
ID: 726392
Canada
• 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
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1991 | Degree: MD | Subject: Medicine | Institution: University of Medicine and Pharmacy, Timisoara |
| Year: 2004 | Degree: MS | Subject: Biostatistics | Institution: Columbia University - Mailman School of Public Health, NY |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2005 to Present | Employer: Undisclosed | Title: Clinical Research Scientist | Department: |
Responsibilities: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 |
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| Years | Employer | Title | Department |
| Years: 2004 to 2005 | Employer: The University of Texas School of Public Health at Houston US | Title: Biostatistician | Department: |
Responsibilities: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). |
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| Years | Employer | Title | Department |
| Years: 2000 to 2004 | Employer: Cardiovascular Research Foundation - NY US | Title: Research Fellow | Department: |
Responsibilities:He worked as research fellow, on phase II and III trials, in interventional cardiology |
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| Years | Employer | Title | Department |
| Years: 1994 to 1999 | Employer: APIC International Romania | Title: Medical Science Liaison | Department: |
Responsibilities: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 |
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| Years | Employer | Title | Department |
| Years: 1993 to 1994 | Employer: Private Practitioner | Title: Family Medicine | Department: |
Responsibilities:He provided primary care devoted to comprehensive health care to people of all ages. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2000 to 2005 | Country / Region: United States | Summary: |
| Years: 1993 to 1999 | Country / Region: Romania - Europe | Summary: |
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 and Patents Summary |
|---|
| He has 3 research grants, 2 peer-reviewed articles, 6 non peer-reviewed articles, more than 25 posters and abstracts |
Language Skills
| Language | Proficiency |
|---|---|
| Romanian | His native language |
Fields of Expertise
antineoplastic protocol, applied statistics, biological response, biostatistics, bivariate analysis, chi-square method, clinical protocol, clinical trial, continuous distribution function, data correlation, discriminant analysis, factor analysis, histogram, Kolmogorov-Smirnov test, medical statistics, metastasis, mutagenesis, oncogenesis, pathologic process, pharmacoepidemiology, reproductive epidemiology, sampling plan, skewed density function, statistic, statistical data analysis, statistical design of experiments, statistical inference, statistical median, statistical method, statistics, estimate, cancer epidemiology, education statistics, design of experiments, multivariate calibration, normal distribution, statistical sampling plan, flexible statistical model building, multivariate statistical analysis, tumor biology, cancer biology, acceptance sampling, accuracy, normal density function, nonparametric statistics, multivariate analysis, antigen-antibody interaction, angiogenesis