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Basic Biostatistics In Clinical Research

Introduction
Loudon Far East (LFE) China is a wholly foreign owned legal entity in China. LFE provides marketing research and business consulting services, and specific CRO services such as Patient Referral and Clinical Data Management (CDM) for the top pharmaceutical and healthcare multinational companies.
The field of biostatistics has become increasingly important in the pharmaceutical and healthcare industry, from the process of molecule screening, selection of molecules, clinical trials, applications to SFDA, FDA and EMEA, launch of products to post-marketing data. Biostatistics covers everything from development and application of statistical techniques to scientific research in medicine, epidemiology, and public health.
This course will guide you through basic statistics in an interesting and interactive format. The theory of statistics will be illustrated with relevant market analysis illustrations to ensure a practical understanding.


Who willbe benefit
CRA, Senior CRA, medical advisor, data manager, medical affair, medical information staff, clinical trial manager, project leader, regulatory affairs, QA and safety official.


Outline of the seminar

The training focuses on:

Part I Statistical Concepts and Terminology

Population

Sample

Parameter/variable/statistic


Part II Descriptive Statistics

Central Tendency

Dispersion

Distributions


Part III Inferential Statistics

Terminologies: α β p-value

Point and interval estimates of mean

Hypothesis Testing

Regression

Survival Analysis


Part IV Statistical Considerations In Clinical Trial Design

Study Design

Clinical Endpoint

Demonstrating Superiority/Equivalence

Non-inferiority

Randomization, multiplicity & sample size


Speaker at Basic Biostatistics in Clinical Research

Fangqui Xiao (Jimmy Xiao) will be the lecturer. He is the Head of Data Management & Statistics at Loudon Far East, MD, bachelor in Public Health, 3 years of experience as a doctor in a municipal hospital of Shanghai, then 3 years as an epidemiological data analyst in Institute Of Petrochemical Health, SMU. His industry experience includes CRA for Schering-Plough, biostatistics manager in the medical division of Shanghai Roche, and biostatistics manager of R & D in AstraZeneca, China. He has more than 13 years of experience in statistics and development of SAS macros and CDM systems for clinical studies. Jimmy Xiao has chaired biostatistics trainings and has given lectures forin international pharmaceutical companies.