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Careers
Position: Biostatistician, Associate Director/Director
Location: Shanghai/Beijing, China
Report Line: Head of Biometrics

Job Summary

The Biostatistician is to provide critical statistical expertise and technical support to the experimental design and the evaluation, interpretation of experimental results in research projects and clinical trials. The Biostatistician will be able to solve complex problems within own area and will participate in multidisciplinary teams.

Key Responsibilities

• Identify the statistical methodology to establish study strategy (e.g. power modelling of different scenarios, set up power monitoring, set up mitigation plan to minimize the risk of statistical failure)

• Provide input for the protocol (design, objectives, endpoints, randomization strategy, sample size, stat analysis) and for the study set-up

• Act at all times as the subject matter expert: provide statistical expertise in specific topics and training of peers

• Analyze internal and external information to make decision on study design

• Provide input to the regulatory submissions including specification of overview documents and response to regulatory questions

• Keep update on knowledge of best practices and new statistical innovation 

• Identify opportunities for the application of modelling and simulation to improve study design

• Identify opportunities to improve the methodology and provide practical solutions for clinical development

• Deliver tasks to plan and interpreting analyses results

• dentify and apply statistical methodology to improve the process and provide practical solutions for research/production activities

• Contributes to the development, sharing and statistical support of new procedures, tools or techniques to improve quality, efficiency and effectiveness of own area 


Requirements

• Master degree, specific to Statistics, Engineering, Life Sciences, Computer Sciences, Mathematics and Physics or equivalent.  PhD degree is preferred 

• Fluent English (oral and written)

• Minimum 7 years of experience in pharmaceutical industry

• Has been previously responsible for studies with different designs (dose range, superiority/non-inferiority, interim analysis rules, etc.)

• Experience in SAS software and sample size computation for standard designs including simulations

• Ability to work in a multidisciplinary team (e.g. give guidance to non-stat, provide feedback, engage)

• Knowledge of relevant legislation/developments in Clinical Development and Biostatistics

• Experience as a statistician in the health care environment or relevant areas of statistical applications

• Experience with relevant software and processes

• Ability to apply statistical techniques in the analysis of data from clinical studies or other relevant area