Home : Leadership : Jonathan Ma

Jonathan Ma, PhD

POSITIONS HELD 

July 2001 – Present                 Associate Director/Biometrics
                                                Clinical Data Operations         
                                                Pfizer Pharmaceutical Group, Pfizer Inc
                                                New York, New York 

Primary statistician supporting clinical trials on the lipid lowering agent Lipitor in the Cardiovascular/Metabolic division. Handling all statistical issues for the Phase 3/4 studies and providing statistical support to relevant clinical teams and marketing teams, including study design, SAP writing, study conduct/monitoring, various committee and investigator/coordinator meetings, TLF generation, study report writing, response to regulatory requests, etc.  Overseeing CROs on all statistical deliverables.  Taking lead of the biometrics team to support other medical and marketing initiatives, such as marketing promotion materials, publications, annual safety report, etc.        

 March 2000 – July 2001          Manager, Biostatistics
                                                Ingenix Pharmaceutical Services
                                                Chevy Chase, Maryland 

                                                Managed biostatistical work and played a key role in providing biostatistical support to projects as follows: Acted as a lead biostatistician on project teams; overviewed the project progress; organized responses to issues and requests raised by sponsors or regulatory agencies in a timely and effective fashion; met with sponsors as requested during protocol development to ensure adequacy of proposed study designs with respect to statistical feasibility; provided biostatistical consultation from the regulatory perspectives; wrote statistical sections of study protocols and formal statistical analysis plans to be carried out in the analysis of clinical studies; interacted with other Ingenix International departments to ensure a high level of client satisfaction. 

October 1995 - March 2000    Mathematical Statistician
                                                U.S. Food and Drug Administration
                                                Rockville, Maryland 

                                                Provided statistical evaluation for investigational new drug applications (INDs) and new drug applications (NDAs) submitted by drug companies.  Reviewed therapeutic areas included anesthetics, addiction, metabolic and endocrine, antiviral and pre-clinical carcinogenicity studies.  Evaluated the techniques and interpretation of the statistical analyses performed by drug companies and identified potential problems and biases.  Performed appropriate alternative analyses to verify sponsor’s conclusions.  Worked closely with other members of the review team, including Medical Officer, pharmacologist, pharmacokinetist, etc., and provided consultation on all statistical issues risen from their review processes.  Periodically reported review progress and major statistical issues identified during the review process to division directors and other members of the review team on internal status review meetings.  Attended sponsor meetings and teleconferences and provided guidance and consultation on issues related to study design and statistical analysis. 

                                                Wrote statistical evaluations and/or reports on 12 NDAs, dozens of INDs and other projects.

September 1991 - May 1995   Yale University
                                                New Haven, Connecticut  

                                                Research Support Specialist - Worked in the Biostatistics Consulting Unit as a consultant and analyzed data from various research projects using both parametric and non-parametric statistical techniques.

                                                Research Assistant – Applied statistical modeling techniques to link between the incidence and mortality rates of lung cancer from the Connecticut Tumor Registry data.

                                                Teaching Assistant - Directed group discussions for basic statistical courses.

June 1992 - August 1992         Summer Intern
                                                Bristol-Myers Squibb Pharmaceutical Company
                                                Wallingford, Connecticut 

                                                Analyzed data from clinical trials comparing drugs for treating HIV infection: AZT, DDI and D4T.  Finished a complete SAS package for a two-sample asymptotically distribution-free test for incomplete multivariate distributions. 

May 1990 - July 1991             Research Assistant
                                                The University of Texas at El Paso
                                                El Paso, Texas 

                                                Developed nonparametric estimators for the survival functions of stochastically ordered random variables.

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