Richard Li

Current

• Senior Consultant Biostatistician at CV Therapeutics

Past

• Senior Consultant Biostatistician at Amgen
• Senior Consultant Biostatistician at Sanofi Pasteur
• Consultant Biostatistician at Allergan

• Biostatistician at Sanofi Pasteur
• SAS programmer at Phoenix International
• Statistical Analyst at Montreal General Hospital

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3 more...

Education

• McGill University
• Beijing Institute of Technology
• Tsinghua University

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Connections

32 connections

Industry

Pharmaceuticals

Richard Li’s Summary

THERAPEUTIC EXPERIENCE

• Immunology
• Oncology
• Dermatology (BOTOX)
• Cardiovascular
• Ophthalmology
• PK/PD studies
• Vaccination
• Rheumatoid Arthritis
• Respiratory Disease
• Nephrology
• Asthma
HIGHLIGHTS OF QUALIFICATIONS

• Experienced in writing statistical
section of protocol
• Experienced in writing Clinical Study
Reports for both interim and final
• Experienced in writing Statistical Analysis Plans (SAPs) and Table Shells
• Experienced in writing IND annual reports
• Experienced in writing and validating statistical part of study manuscripts for publication
• Experienced in protocol design
• Experienced in non-inferiority test
• Experienced in superiority test
• Experienced in equivalence test
• Experienced in bioequivalence test
• Experienced in survival analysis
• Experienced in sample size calculation and power calculation
• Experienced in PK/PD studies
• Experienced in randomization scheme
• Experienced in Cox, logistic and linear regression
• Experienced in ANOVA and ANCOVA analysis
• Experienced in parametric and non-parametric analysis
• Experienced in repeated measurement analysis
• Experienced in inter-rater and intra-rater variability analysis
• Experienced in simulation technique
• Experienced in cross-over design
• Familiar with sequential design
• Familiar with propensity score methodology

Richard Li’s Specialties:

COMPUTER SKILLS
• SAS (BASE, STAT, MACRO, GRAPH)
• Splus
• Microsoft Office
• nQuery
• WinNonlin

Richard Li’s Experience

• Senior Consultant Biostatistician

  CV Therapeutics

  (Public Company; 501-1000 employees; CVTX; Biotechnology industry)

  July 2006 — Present (3 years 9 months)

  • Participating in designs of clinical trials.
  • Attending weekly project team meeting.
  • Writing statistical section of clinical trial synopsis
  • Writing statistical section of clinical trial protocol.
  • Writing statistical analysis plans (SAPs) and table shells.
  • Writing statistical analysis report.
  • Calculating sample size and power.
  • Writing randomization plan and generating randomization list.
  • Calculating Pharmacokinetics parameters via WinNonlin.
  • Conducting CRO for statistical analysis.
  • Supporting NDA submission via reviewing and validating analysis results
  • Doing ad-hoc tasks requested by clinical team.
  • Therapeutic fields: Cardiovascular, Asthma, Pharmacokinetics
  Clinical trials: Phase I (Pharmacokinetics), Phase II and Phase III; in charge of 6 studies as study and project biostatistician

• Senior Consultant Biostatistician

  Amgen

  (Public Company; 10,001 or more employees; AMGN; Biotechnology industry)

  June 2005 — July 2006 (1 year 2 months)

  • Writing Clinical Study Reports for both interim and final.
  • Writing statistical analysis plans (SAPs) and table shells.
  • Writing and reviewing statistical part of study manuscripts for publication.
  • Doing statistical analysis.
  • Validating statistical results produced by SAS programmers.
  • Doing ad-hoc tasks requested by clinical team.
  • Therapeutic fields: Nephrology
  Clinical trials: Phase IV; in charge of 2 studies as study biostatistician

• Senior Consultant Biostatistician

  Sanofi Pasteur

  (Public Company; 10,001 or more employees; sny; Pharmaceuticals industry)

  March 2005 — June 2006 (1 year 4 months)

  • Participating in clinical trial design.
  • Writing statistical section of protocol.
  • Writing IND annual reports.
  • Writing statistical analysis plans (SAPs) and table shells.
  • Calculating sample size and power as requested by clinical team.
  • Providing statistical method advice to clinical team.
  • Answer the questions raised by regulatory agency.
  • Reviewing iCSR and preparing answers to questions raised by regulatory agency.
  • Doing ad-hoc tasks requested by clinical team.
  • Validating tables produced by other persons.
  • Therapeutic fields: Vaccine Immunization
  • Clinical trials: Phase I, Phases II, Phase III and Phase IV; in charge of 2 studies as study biostatistician

• Consultant Biostatistician

  Allergan

  (Public Company; 5001-10,000 employees; AGN; Pharmaceuticals industry)

  August 2003 — August 2004 (1 year 1 month)

  • Writing statistical analysis plans (SAPs) and table shells.
  • Assisting in clinical trial design.
  • Review clinical statistical report to answer questions raised by regulatory organization.
  • Providing statistical method advice to clinical team, such as through simulation method to get confidence interval and power.
  • Calculating sample size as requested by clinical team.
  • Quality control for statistical analysis plan, table shell, analysis data set and final table/listing/graph for clinical trials.
  • Writing independent SAS codes to validate Analysis Data Set and TLG results.
  • Finished 10 SAPs independently.
  • Therapeutic fields: Eye Care, Dermatology and Migraine
  • Clinical trials: Phase I, Phases II, Phase III and Phase IV

• Biostatistician

  Sanofi Pasteur

  (Public Company; 10,001 or more employees; sny; Pharmaceuticals industry)

  July 2000 — August 2003 (3 years 2 months)

  •• Designing protocols for clinical trials (phases I through IV) by providing advice in sample size and randomization scheme, writing statistical analysis plans (SAPs), writing SAS code for statistical analysis plans, running statistical analysis and writing clinical statistical reports.
  • Therapeutic fields: Respiratory disease, Oncology, and Immunology
  • Clinical trials: Phase I, Phases II, Phase III and Phase IV
  
  Involved in the following projects:
  • Investigational product: The product will be used for childhood immunization. Phase III through phase IV: Design protocol, calculate sample size, and write Statistical Analysis Plan
  • Investigational product: The product is used to treat bladder cancer. Phase III: Review protocol and clinical statistical report. Write independent SAS programs to validate dataset, tables, figures and listings. Redo statistical analysis in order to apply license in Japan

• SAS programmer

  Phoenix International

  (Public Company; 201-500 employees; PHXX; Computer Software industry)

  July 1999 — December 1999 (6 months)

  • Writing SAS programs for clinical trial project (Phase III study)
  • Creating Tables, Listings and Figures based on the submission required
  • Doing statistical analysis
  • Therapeutic field: Cardiovascular (Vasomotor Disease)
  • Clinical trials: Phase III

• Statistical Analyst

  Montreal General Hospital

  (Hospital & Health Care industry)

  April 1993 — July 1998 (5 years 4 months)

  • Design of statistical models for clinical trials and medical research
  • Conducted research into the mathematical basis
  • Provided information in the scientific field
  • Gathered, analyzed and interpreted data
  • Researched, evaluated and provided recommendations concerning the application of statistical methods
  • Prepared reports
  • Therapeutic field: Rheumatoid Arthritis and Cardiovascular Disease

Richard Li’s Education

• McGill University

  1991 — 1994

• Beijing Institute of Technology

  Master , Engineering , 1984 — 1987

• Tsinghua University

  Bachelor , Engineering , 1979 — 1984

Additional Information

Richard Li’s Groups:

•    McGill University Alumni
•    Biostatistics

Richard Li’s Contact Settings

Interested In:

• career opportunities
• consulting offers
• job inquiries
• expertise requests
• reference requests
• getting back in touch