上海招聘

职位描述：
Job purpose
Provide expert statistical contribution to both clinical studies in multiple specified therapeutic areas and Develop people within and outside Biostatistics by sharing statistical knowledge and thinking
Responsibilities
Provide statistical contributions to the local and regional clinical programs.
- Co-authoring of local protocols
- Providing input to CRF, database design and data cleaning plans
- Developing randomization schedule - Authoring statistical analysis plan
- Conducting statistical analysis - Reporting of the statistical results
Provide statistical support to a wide range of local and regional clinical trials and area of expertise(e.g. NIS, ISS, health economics) for both registration and post-marketing promotions
- Provide sample size calculation, result interpretation, potential risk/benefit estimation for the early stage study development plan.
Maintain process standards across the therapeutic areas according to SOPs, China CFDA requirements and international ICH guidelines with regard to statistics.
- Develop positive communication channel with clinical, marketing/strategy, regional, regulatory and global statistician to ensure quality and effective work.
Develop people by Increasing statistical knowledge
- Provide guidance and coaching to less experience statisticians
- Give statistical presentation at regular R&D New Staff Orientation Training
- Provide tailored statistics training to other groups if required, e.g. to data management team, CRAs physicians, Regulatory Affair team, and commercial team
Demonstrate technical leadership/coordination and project management skills.
- Management of statistical work contracted out to a CRO or research collaborator
- Provide expert statistical thinking to support the regulatory submissions including specification of overview documents and response to regulatory questions
- Help line manager and study team leader to maintain/update risk management, project timetable and resource estimation.

Requirements:
Academic / Professional qualification
- Masters degree or Ph.D. in Biostatistics
Technical / skills training
- Application of a wide variety of statistical techniques in clinical development
- SAS programming
- Industry SOPs relating to statistics and local China health authority requirements
- Coaching and performance management - Project management
- Ability to negotiate and influence other team members - Initiative
Experience :
- 2-3 years experience at a multinational pharmaceutical company or Clinical Research Organization (CRO) as a biostatistician.
- Extensive experience of data analysis using a wide variety of statistical methods
- Extensive experience from designing to reporting in several clinical studies
- Experience of regulatory consultations
- Experience of drug development in several phases
Desirable
- experience in cross functional team settings
- Experience of drug development from Phase I to commercialization
Language ability
- Fluency in English in addition to Mandarin as a first language
Computer literacy
- The incumbent must be familiar with the functions and capabilities of the software and hardware on which biometrics depends, as well as the concepts of biometrics and how they relate to available technology and to the other functions engaged in the clinical research process. 举报 分享

   海和药物专注于抗肿瘤创新药物发现、开发及商业化，以“海纳百川，和谐共赢，创新为本，造福人类”为使命，坚持走自主创新的道路，寻求中国原创和创新药物的国际开发之路。


海和药物拥有一支中国工程院院士领衔的管理团队，注重创新，经验丰富，建立了以“生物标志物指导下的”精准医疗平台；建全了以技术先进、运行规范并与国际接轨的新药临床前评价体系和临床研究体系，涵盖药物开发、CMC研究、生物标志物发现和确认、医学战略规划以及临床研究等单元系统；打造了优势叠加、颇具国际竞争力的新药研发体系和产品管线。公司现拥有临床化合物 7个，临床前化合物 3个，其中7个是原创新药。