Jeng Mah
Summary
Accomplished biostatistician with extensive experience at Beckman Coulter, Inc., specializing in clinical trial design and statistical analysis. Proven ability to mentor teams and enhance productivity while employing advanced statistical techniques, including Bayesian modeling. Recognized for delivering impactful insights that drive regulatory compliance and product approvals.
Overview
45
45
years of professional experience
Work History
Independent Statistical Consultant
Independent Statistical Consultant
01.2025 - Current
- Conducted consultations on study design and FDA submission strategies for IVD instruments.
- Reviewed clinical protocols to ensure adherence to regulatory standards.
- Developed tailored statistical analysis plans to meet specific project requirements.
- Performed power analyses and sample size calculations to enhance robustness of studies.
Senior Staff Biostatistician
Beckman Coulter, Inc.
01.2012 - 01.2025
- Supported over 20 new and re-developed immunoassays, enabling CE mark and FDA approvals.
- Designed and analyzed clinical trials in collaboration with cross-functional teams.
- Authored comprehensive statistical analysis plans, ensuring adherence to regulatory standards.
- Conducted assay migration studies in preparation for launching a new instrument platform.
- Developed statistical models for diagnostic and clinical research projects.
- Mentored fellow statisticians, enhancing team expertise and productivity.
- Consulted with scientific teams to refine study designs effectively.
Senior Principal Advisor, Biostatistics
Regulator and Clinical Research Institute (RCRI)
01.2008 - 01.2011
- Provided extensive statistical and regulatory support for new medical product applications involving over 30 products in various therapeutic areas.
- Acted as statistician for DSMB and participated in mock FDA panel reviews.
- Executed interim and final analyses, performing document validation and communicating study results effectively.
- Advised peers and clients on statistical methodologies to improve project outcomes.
- Cultivated a collaborative atmosphere that encouraged teamwork between departments.
- Partnered with senior executives to develop strategic plans aimed at achieving key objectives.
Principal Biostatistician
American Medical Systems
01.2006 - 01.2008
- Developed and implemented MDR and product warranty database surveillance programs.
- Created automated applications for clinical study report generation.
- Provided statistical support for over 15 clinical studies, including feasibility and pivotal trials.
- Advised management on strategies for conducting post-market clinical trials.
- Executed statistical analyses for clinical trials, ensuring regulatory compliance.
- Collaborated with cross-functional teams to establish statistical methodologies for novel diagnostics.
Principal Biostatistician
Guidant CRM
01.1996 - 01.2006
- Executed over 25 IDE studies and secured FDA and CE approvals for 10+ CRM devices.
- Provided statistical support for product reliability analyses and post-market safety surveillance of pacemakers and defibrillators.
- Delivered comprehensive statistical consulting across CRM; mentored fellow statisticians and supported research initiatives.
- Chaired Guidant's Technical Advisory Council from 2003 to 2004, recognized by peers for expertise.
- Collaborated with cross-functional teams to formulate statistical methodologies for innovative diagnostic tests.
- Implemented quality control measures to enhance data integrity and reliability throughout projects.
- Conducted power analyses to refine sample sizes and study designs in clinical trials.
- Drafted detailed statistical sections of study protocols, addressing rationale, objectives, design, and methodology.
Biostatistician
Caremart/Minneapolis Medical Research Foundation
01.1995 - 01.1996
- Completed and validated the Medicare ESRD database conversion project
Senior Research Analyst
Foundation for Healthcare Evaluation
01.1993 - 01.1995
- Conducted comprehensive analyses of healthcare data, identifying trends and offering actionable insights.
- Presented research findings to stakeholders, transforming complex data into concise recommendations.
Graduate Assistant
Colon Cancer Control Study, Department of Environmental Occupational Health
06.1991 - 09.1993
- Created advanced staging algorithm for colon cancer emphasizing survival analysis
Postdoctoral Research Associate, Graduate Assistant
North Dakota State University
01.1981 - 02.1990
- Implemented, executed, and supervised USDA research project focused on blackbird damage control.
Education
Completed lower-division coursework for B.S.E.E - Electrical Engineering
University of Minnesota
Minneapolis, MN01.2003
M.S. - Biostatistics
University of Minnesota
Minneapolis, MN01.1993
Completed coursework in Biostatistics Ph.D. program -
University of Minnesota
Minneapolis, MN01.1993
M.S. - Applied Statistics
North Dakota State University
Fargo, ND01.1989
Ph.D. - Zoology
North Dakota State University
Fargo, ND01.1988
M.S. - Animal Science
North Dakota State University
Fargo, ND01.1984
B. S. - Animal Husbandry
Chung-Hsing University
Taiwan01.1974
Skills
- Statistical analysis techniques
- Clinical trial design
- Sample size estimation
- Frequentist and Bayesian modeling
- Survival and categorical analysis
- Nonparametric methods
- Generalized estimating equations
- Multivariate analysis
- Computational methods
- Bootstrap and Monte Carlo simulations
- Decision trees and classification
- Statistical decision analysis
- Health economics analysis
- SAS and R programming
- MATLAB and S-Plus usage
- FORTRAN and Visual Basic expertise
- Animal studies and lab experiments
Knowledge And Skills
- Statistics - proficient in statistical techniques with creative insight. Experimental design; sample size; frequentist and Bayesian modeling; survival, categorical, nonparametric, general linear mixed models, GEE, ZIP; multivariate analyses; computing-intensive methods, e.g., bootstrap, Monte Carlo, classification, and decision trees
- Statistical and health economics decision analysis
- Simulation - SAS: 30+ years' experience; BUGS, MATLAB, SPlus, R, FORTRAN, Visual Basic on various operating systems
- Research - animal studies and lab experiments, including as principal investigator
Additional Education
- 2003, Completed lower-division coursework for B.S.E.E (Electrical Engineering), University of Minnesota
- 1993, Completed coursework in Biostatistics Ph.D. program, University of Minnesota
Accomplishments
FDA Appreciation Award (100-year anniversary in 2006)
Timeline
Independent Statistical Consultant
Independent Statistical Consultant
01.2025 - Current
Senior Staff Biostatistician
Beckman Coulter, Inc.
01.2012 - 01.2025
Senior Principal Advisor, Biostatistics
Regulator and Clinical Research Institute (RCRI)
01.2008 - 01.2011
Principal Biostatistician
American Medical Systems
01.2006 - 01.2008
Principal Biostatistician
Guidant CRM
01.1996 - 01.2006
Biostatistician
Caremart/Minneapolis Medical Research Foundation
01.1995 - 01.1996
Senior Research Analyst
Foundation for Healthcare Evaluation
01.1993 - 01.1995
Graduate Assistant
Colon Cancer Control Study, Department of Environmental Occupational Health
06.1991 - 09.1993
Postdoctoral Research Associate, Graduate Assistant
North Dakota State University
01.1981 - 02.1990
Completed lower-division coursework for B.S.E.E - Electrical Engineering
University of Minnesota
M.S. - Biostatistics
University of Minnesota
Completed coursework in Biostatistics Ph.D. program -
University of Minnesota
M.S. - Applied Statistics
North Dakota State University
Ph.D. - Zoology
North Dakota State University
M.S. - Animal Science
North Dakota State University
B. S. - Animal Husbandry
Chung-Hsing University