What Does a Statistician Do in a Pharmaceutical Company

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What Does a Statistician Do in a Pharmaceutical
Company?

• Wei Tian, Ph.D.

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I. Overview of Drug Development

• Step 1. Pre-clinic
• Identify A Compound?Screening Tests
  ?Formulation ?Toxicological Animal Studies
• Step 2. Clinical Studies
• Phase I Tolerability Studies and
  Pharmacokinetic Studies ?Phase II Dose- finding
  Studies ?Phase III Pivotal Studies
  ?Dossier/Regulatory Submission

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I. Overview of Drug Development (Continued)

• Step 3. Marketing
• Step 4. Post-marketing
• Phase IV Studies

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II. The Role of a Statistician in Drug
Development

• Statistics is Applied Everywhere in Drug
  Development
• Focusing on Clinical Trials
• Based on Personal Experience

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II.1 Overview of Clinical Trials

• Planning?Protocol?Case Report Forms ?Conduct of
  the Trial?Database Preparation?Statistical
  Analyses?Study Report

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II.2 Developing Study Protocol

• Study Objectives
• Study Design
• Endpoints
• Statistical Methodology
• Sample Size Determination

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II.3 Data Collection/Case Report Forms (CRF)

• Collecting Patients Information during the Trial
  so that the Data can be Analyzed and Summarized
  per Protocol
• Are all the measurements required in the protocol
  included?
• Are the data fields analyzable?

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II.4 Randomization

• Why Randomized Trial?
• Comparability
• Avoid Bias
• Developing Randomization Schedule
• Implementing Randomization

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II.5 Conduct of the Study

• Relatively Less Involvement of Statisticians
• Interim Analysis

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II.6 Data Management

• Statistician Works Closely with Data Management
  Group
• Milestone Database Lock!!!

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II.7 Performing Data Analysis

• Statistical Analysis Plan (SAP)
• Tables, Listings, and Figures
• Exploratory Analyses
• Collaboration between Statisticians and
  Programmers

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II.8 Writing Study Report

• Statisticians Contribution of Presenting Data
  and Interpreting Analysis Results
• Final Product of a Clinical Trial

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III. Another AspectStatistical Research

• Keep up with Evolution
• Stay Marketable

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IV. Be a Good Statistician

• Statistical Knowledge
• Communication Skill
• Regulatory Requirements
• Motivation

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V. The Company I Work for

• Inspire Pharmaceuticals, Inc.
• Founded in 1995 160 Employees
• Strong Scientific Expertise in Ophthalmology,
  Respiratory and P2 Receptor Technology
• Strong Proprietary Position - Approximately 50
  Issued U.S. Patents

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V. The Company I Work for (Continued)

• Top 100 Biotechnology Companies in the Nation
  July 2005, MedAdNews
• Best Places to Work Award, 2005 The Triangle
  Business Journal
• Top 10 Best Employers in North Carolina, 2004
  NC Business Magazine

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VI. Contact Information

• Companys website
• www.inspirepharm.com
• My e-mail address
• wtian_at_inspirepharm.com