> Dear Allstaters,
>
> Working for this major Pharmaceutical client you will be a key player in a
> renowned team of Statisticians.
>
> TITLE: Senior Expert Statistician
>
> * Be the independent statistical leader and project manager for all
> B&SR deliverables globally for a large and technically complex clinical
> development program, including supervisory functions like appraisals of
> full-time team members.
> * Ensure that clinical development program meets scientific,
> regulatory, quality and commercialization requirements, through
> interaction with the IPT and ICT (e.g., drive CDP and TPP development from
> a statistical perspective).
> * Be a scientific leader/expert within a TA, showing leadership/be the
> point of refer-ence in statistical methods, regulatory guidelines, project
> strategies, clinical devel-opment planning and study design in specific
> indications.
> * Perform matrix management of B&SR project team, and mentor staff as
> required.
> * Ensure quality of scientific contributions, integrating input from
> ECD-Biostatistics, Methodology, Modeling and Simulation and external
> experts. Initiate and drive inno-vation by implementing novel methods and
> innovative designs.
> * Plan and track project level activities for B&SR, including
> resources.
> * Establish and maintain project standards (master analysis plan, full
> development project specifications).
> * Plan and manage submission activities, like SCS, SCE, briefing
> books.
> * Participate in/lead non-clinical project activities.
> * Interact with Health Authorities and external consultants as
> appropriate. Support and defend analyses and their interpretation at
> Health Authority Meetings. Take sig-nificant Biostatistics leadership role
> at FDA Advisory Committee meetings.
> * Evaluate in licensing opportunities.
>
> £ Excellent Salary + Benefits + Relocation Package
>
> If you are interested in this role please get in contact ASAP for a
> confidential chat and more details.
>
> Regards
>
> James Carrera
> European Contracts Manager
> Pharmaceutical, Healthcare & CRO division.
> 1st IT People
> Tel: +44 (0) 207 940 3900
> Fax: +44 (0) 207 886 8161
> mailto:[log in to unmask]
> www.1st-itpeople.com
>
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