Company: Docs Global (Continental Europe)
Reference: Ref AS-019761
Closing Date: 12 Dec 16
Salary (£): Competitive
Benefits: Excellent & Comprehensive
In this role you ensure comprehensive and optimized statistical input from early development to submission and life cycle management as well as “state-of-the-art” biostatistical methodology and compliance with guidelines, GCP and alignment of systems and processes to company and global standards. In this position, your role will be to lead the statistical aspects for a global development project.
Roles & Responsibilities of the position
• As member of project teams, ensuring that clinical development program meets scientific, regulatory, quality and commercialization requirements.
• Acting as leader for all biostatistical deliverables for a clinical development project, including the coordination and supervision of trial biostatisticians allocated to the project as well as ensuring that methodological and operational biostatistical experts are involved as appropriate and needed for the project.
• Acting as project manager for all the statistical deliverables for a clinical development project, including the planning and tracking of project level activities, resource management, planning and managing submission activities.
• Setting the strategic direction for addressing statistical issues in regulatory submissions and directly influence drug development decisions with internal and external partners as well as driving and coordinating the quantitative approach to decision making process at development milestone.
• Implementation of state-of-the-art and innovative trial designs, statistical models, and analysis methodologies and ensuring full integration of modern quantitative aspects of drug development.
• Establishing and maintaining project standards, project SAP including the development of ISS/ISE.
• Being responsible for successful interactions with Health Authorities, Pricing and Reimbursement agencies, Planning and managing submission activities.
• Overseeing vendors and set up collaborations with scientific experts.
• PhD or MSc in Statistics or equivalent
• Several years of experience as project biostatistician and experience in a pharmaceutical company
• Solid knowledge of biostatistical methods & techniques
• Solid experience with drug development process, HA guidelines and Regulatory Authorities Interactions
• Good knowledge of statistical software packages (e.g. SAS, R, ...)
• Fluent verbal and written English language skills
• Being a teamplayer and in matrix organization
• Project management, communication and presentation skills
• International and intercultural working experience
We offer an exciting and challenging role in an international environment where you can make a difference and where you can learn and grow.
Salary: €70-90,000.00 dependant on experience
Bonus: €8.5-10,000.00 dependant on experience
Pension and Life Insurance
German lessons if required
If you feel that this is just the right job for you, please submit your application here online!
2 Globeside, Globeside Business Park
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