Expert Details

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

Expert ID: 726392 Canada

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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




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 Responsibilities
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
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).
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
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
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.

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

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