Ersen Arseven Ph.D., Statistical and Process Consultant, Clinical and Non-clinical Drug Development, 845-358-4636
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Professional Experience

Statistical and Process Consulting

May 1992-Present

Provides innovative and sound approaches to enable global development, registration, and licensing of biopharmaceuticals, biologicals, diagnostic tests, and contrast agents. Services offered include:

  • Development of statistical design, analysis, presentation strategy, and methodologies. Implementation of strategy for a specific product development and registration.
  • Integration of scientific evidences for efficacy and safety summaries. Review and evaluation of clinical dossiers, pre-clinical safety and CMC sections, integrated summaries, clinical trial reports, protocols, and methodologies.
  • Due Diligence for licensing and investment decisions by companies and venture capitals.
  • Evaluation and validation of pre-clinical and clinical study results and methodologies reported in prospectus portfolios.
  • Assessment of the quality of submitted work and its acceptability by regulatory agencies to establish safety and efficacy.
  • Project and resource management for operational staging of global clinical development projects.
  • Management and organizational consulting for drug development process.
  • Development of knowledge bases for therapeutic areas and for products to leverage knowledge accumulated during the development phase to facilitate smooth transitioning of product from development team to marketing team for more effective market introductions.

Schering-Plough Research Institute, Kenilworth, NJ
Statistics and Statistical Programming, Director Non-Clinical Statistics

February 2003-June 2005

Directed activities of groups of statisticians that provided statistical design and analysis services to:

  • Discovery Research Division
  • Chemical and Pharmaceutical Sciences Division
  • Safety Sciences Division of the Research Institute

Prepared and reviewed statistical components of Chemistry-Manufacturing-Control (CMC) and Safety Sections of regulatory submissions. In discussions with regulatory agencies, provided defense of statistical methodology and conclusions.

Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
Scientific Affairs Division Group Director with Worldwide Responsibility

December 1990-May 1992

For worldwide company, as a member of the International Medical Committee, evaluated the medical and operational staging of global development projects. Managed the development and implementation of statistical design, analysis, and data management of global projects. Led the design and implementation of processes to produce submissions dossiers from standard components.

For U.S. operations unit, directed statistical design and analysis, data management, document processing, and archiving services for the R&D and Medical Divisions. Directed development and implementation of systems and office automation to enable effective functioning of Medical Affairs Division. Staff of 77 and budget of M$6.5.

Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
Medical Affairs Division Director, Medical Data and Administrative Services

May 1988-December 1990

Directed the activities of seven departments in two divisions: Statistical Design and Analysis, Clinical Trial Information, Clinical Trial Support, Medical Systems, Medical Planning and Budgets, Project Management, and Medical Grants and Contracts. Directed development and implementation of systems and procedures to improve planning and control of clinical drug development project activities and costs. Set information technology direction. Prepared and monitored the Medical Affairs Division budget and expenses. Staff of 83 and budget of M$30.

Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
Medical Affairs Division Director, Medical Data Services

July 1984-May 1988

Established effective Statistical Design and Analysis, Data Management, Document Management, and Medical Systems Departments. Developed and implemented Biometric Process to enable global clinical development of our drugs ahead of competitors. Led international task force to develop worldwide clinical data management procedures and standards. Achieved and maintained a zero backlog in processing and analysis of clinical trial data through streamlining procedures, upgrading professional staff, and implementation of proper information technology. Directed four departments with staff of 65 and budget of M$4.5.

American Cyanamid Company, Pearl River, NY
Medical Research Division Group Leader, Non-Clinical Statistics

April 1982-July 1984

Managed group of Statisticians that provided statistical design and analysis services to: Biological Discovery, Analytical Services, Pharmacodynamics and Pharmacokinetics, Process Development, Formulation, Stability Testing, and Toxicology. Developed systems for Analysis of Toxicology Data and Quality Control of vaccine production.

Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
Medical Affairs Division Manager, Statistical Evaluation

February 1978-March 1982

Established the Statistical Design and Analysis Department. Served as company expert for defense of statistical methodology and conclusions before regulatory agencies. Linked the activities of Clinical Research with R&D.

American Cyanamid Company, Pearl River, NY
Medical Research Division Research Statistician

January 1975-February 1978

Designed and analyzed clinical trials in anti-infectives, ocular hypertension, vaccines, and inhaled steroids. Designed and implemented biological screens in drug discovery to identify potential drugs in targeted therapeutic areas. From these screens, one anti-cancer compound, Mitoxantrone, was identified and successfully developed and marketed for treatment of leukemia.

Education

Ph.D. 1974, Texas A&M University, College Station, Texas

Major: Statistics, emphasis on multivariate analysis, general linear models, design of experiments, and Markov renewal processes. Minors: Operations Research and Mathematics.

Dissertation title: Applications of Graph Theory to PERT Critical Path Analysis.

M.A. 1969, University of Pennsylvania, Philadelphia, Pennsylvania.

Major: Economics

B.A. 1964, Ankara University, SBF, Ankara, Turkey.

Major: Economics and Finance

Professional Societies

American Association for the Advancement of Science

American Statistical Association

American Society for Quality

Institute for Mathematical Statistics

Biometrics Society

Pharmaceutical Manufacturers Association, Biostatistics Steering Committee, 1986-1989

Editorial Board Member, Biopharmaceutical Report, 1999-2001

Honors and Awards

Appointed to the Alumni Advisory Board, Department of Statistics, Texas A&M University

Inducted into the Academy of Distinguished Former Students of the College of Science, Texas A&M University

Received H.O. Hartley Award for Distinguished Service to the Discipline of Statistics, Texas A&M University, Department of Statistics

 

  Ersen Arseven Ph.D., Statistical and Process Consultant, 243 South Blvd., Nyack, NY 10960