Your new role
• Oversee statistical support to multiple project teams. Collaborate with clinical and regulatory leads in defining general strategic approach, creating clinical development plans (CDP), and producing individual protocols. Work independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to project.
• Provide general guidance on definition and documentation of key derived variables needed to support production of tables, listings, and graphs (TLG). Effect consistency of data collection and analysis across project or area. Analysis datasets that are quality controlled, sufficient to produce TLG for reports, and consistent within projects. General compliance with standard data models, e.g. CDISC.
• Plan and track project activities, timelines, and resource use across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity. Accurate plans, well-managed projects, capacity to apply extra resources in urgent situation.
• Ensure mentoring and development of staff. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation. Manage conflict. Productive work environment, individual growth, development of strong contributors. Staff compliance with SOPs and departmental policies.
What you'll need to succeed
• Demonstrated leadership, project management, and interpersonal skills
• Excellent written and verbal Chinese/English communication skills
• Excellent presentation skills to groups of varied size and make up.
• Demonstrated broad knowledge and superior understanding of advanced statistical concepts and techniques
• Proven ability to innovatively apply technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management
• Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development
• Demonstrated in-depth understanding of the regulatory drug submission / approval process regionally and globally
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1229199
Talk to a consultant
Talk to Lunah Wang, the specialist consultant managing this position, located in Shanghai
Unit 1205-1212, HKRI Centre One, HKRI Taikoo Hui, 288 Shimen Road (No.1)