Situated in a beautiful rural area of South East England a World leading
International Pharmaceutical company seeking Expert Statistiican to lead
large programs and mega trials.
Salary Range: £55,000 - £65,000 plus excellent company benefits, including
top Pension scheme.
Requirements:
The Expert Statistician can assume the role of an independent Program
Statistician for
the assigned clinical development projects, or a mega trial.
Major Activities (Describe 8 – 12 main activities )
1. Be the statistical leader and project manager for all B&SR deliverables
globally
for a clinical development program, or a mega trial.
2. Ensure that clinical development program (or parts assigned) meets
scientific,
regulatory, quality, and commercialization requirements, through
interaction with
the IPT and ICT.
3. Perform matrix management of B&SR project team, and mentor staff as
required.
4. Ensure ECD-Bios, and modeling and simulation contribution is fully
integrated
into the project.
5. Plan and track project level activities for B&SR, including resources.
6. Establish and maintain project standards (master analysis plan, full
development
project specifications).
7. Plan and manage submission activities, like SCS, SCE, briefing books.
8. Participate in/lead non-clinical project activities.
9. Interact with Health Authorities and external consultants as
appropriate. Support
and defend analyses and their interpretation at Health Authority Meetings.
Represent
Biostatistics at FDA Advisory Committee meetings.
10. Could take Trial Statistician responsibility as appropriate.
Key Performance Indicators (Indicate how performance for this job will be
measured)
At least Masters Degree in Statistics (or equivalent degree) with 7 years
of experience or PhD with 4 years of experience.
Languages: Fluent English (oral and written).
Please contact Gavin O`Neill for details of this or any other
opportunities on 01273 727 930 or [log in to unmask]
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