Expert Details
Statistical Consulting, Biostatistics, Statistical Support to Litigation
ID: 723393
Pennsylvania, USA
He served as functional manager for statistics, data management, programming, and medical writing worldwide for a major phamaceutical company. His management duties included directing and managing all Biometrics support to discovery/development projects, systems, processes, budgets, standards, and personnel within a global Biometrics unit. His project duties included project statistician, reviewing statistician for protocol/report approval committee, and Project Development Committees.
Products/ServicesServices include but are not limited to:
-Statistical support for litigation and legal research
-Representation as statistical expert for depositions, trials, meetings with regulatory authorities, safety monitoring boards, or other corporate/legal interactions
-Writing statistical methods sections of protocols, grant proposals or technical reports
-Design and analysis of experiments and studies
-Sample size calculations and power analyses
-Providing statistical analysis plans
-Developing randomization schemes
-Performing interim and/or exploratory analyses
-Conducting descriptive, univariate, and multivariate analyses
-Preparing data summaries and presentations
-Interpreting analysis results
-Writing statistical reports
-Providing publication support
He served as clinical project statistician on numerous drug development studies in all phases. This work included providing statistical expertise to study protocols, statistical analysis plans, programming and ad-hoc analyses, and statistical reporting.He served as the statistical expert for GE Healthcare on a variety of internal project committees such as the Protocol/Report Approval Committee, Medical Committee, and Project Development Committee.He served as internal statistical expert for GE Healthcare for correspondence and meetings with regulatory authorities such as the FDA.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1985 | Degree: Ph.D. | Subject: Statistics | Institution: Colorado State University |
| Year: 1983 | Degree: M.S. | Subject: Statistics | Institution: Colorado State University |
| Year: 1980 | Degree: B.S. | Subject: Mathematics | Institution: Pennsylvania State University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 1993 to 2006 | Employer: GE Healthcare | Title: Director, Biometrics | Department: Clinical Research |
Responsibilities:He has been functional manager for statistics, data management, programming, and medical writing worldwide (55 headcount in 4 countries). His management duties included directing and managing all Biometrics support to discovery/development projects, systems, processes, budgets, standards, and personnel within the global Biometrics unit. His project duties included reviewing statistician for protocol and report approval committee, member of Clinical Leadership Team, and member of Project Development Committee.His local management duties included line management of Biometrics groups at the Princeton office. This entailed handling personnel issues, hiring, and enforcing HR policy in US |
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| Years | Employer | Title | Department |
| Years: 1985 to 1993 | Employer: University of Florida | Title: Associate Professor, Statistics | Department: Department of Statistics |
Responsibilities:His duties included statistical methodological research, teaching, advising, departmental and university committees, and professional obligations. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 1998 to Present | Country / Region: Oslo, Norway | Summary: He was the global head of Biometrics with direct reports in Oslo. |
| Years: 1998 to Present | Country / Region: Munich, Germany | Summary: He was the global head of Biometrics with direct reports in Munich. |
| Years: 1998 to Present | Country / Region: Amersham, England | Summary: He was the global head of Biometrics with direct reports in Amersham. |
Career Accomplishments
| Associations / Societies |
|---|
| American Statistical Association, Institute of Mathematical Statistics, Drug Information Association |
| Publications and Patents Summary |
|---|
| He has 17 publications in peer reviewed journals along with over 30 invited or contributed talks/seminars at professional conferences, universities, or industries. |
Additional Experience
| Training / Seminars |
|---|
| "Statistics for Nonstatisticians" course taught internally to marketing and clinical personnel. |
| Vendor Selection |
|---|
| Paricipated in the vendor selection process for a variety of CROs providing statistics, programming, and data management expertise. Also involved in the vendor selection process for electronic data capture and clinical databases. |
| Other Relevant Experience |
|---|
| Specialty areas in Extreme Value Theory, Stationary Processes, Time Series Analysis, Mathematical Statistics, and Biostatistics (with applications in diagnostic imaging). |