Dear Allstat,
Please find below the latest permanent opportunity with Hays Pharma:-
Project Biostatistician
Permanent
Global Pharma
Based in Netherlands(100% Client site)
Competitive salary & package
Key responsibilities:
* Provides consultation and advice in quantitative/statistical, experimental design, and data management issues. Works with the clinical monitor and international team to develop clinical protocols, analysis plans and final study reports for clinical development projects. Plans, coordinates, and produces statistical analyses and summaries in support of product development.
* Member of core clinical team, attend meetings as and coordinates activities with internal data management and programming staff, medical writing and regulatory affairs.
* Be the statistical leader and project manager for all B&SR deliverables globally for a clinical development program
* Ensure that clinical development program (or parts assigned) meets scientific, regulatory, quality, and commercialisation requirements.
* Perform matrix management of B&SR project team, and mentor staff as required.
* 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 ISS, ISE, briefing books.
* Interact with Clinical Data Management as appropriate.
* 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.
* Coach and mentor (sr.) statisticians
* Maintain records for all assigned projects and archive trial / project analysis and associated documentation.
Minimum requirements
* Ideally a PhD or MSc Degree in Statistics/Mathematics or related area
* Minimum of 3 years experience
* English, excellent spoken and written
* Demonstrated sound knowledge of statistical applications.
* Awareness of appropriate regulations and guidance documents.
* Preferably SAS programming knowledge.
* Strong problem solving skills and sound statistical judgment. Technical capability to address common statistical problems arising in work.
* Attentiveness to detail.
* Strong interpersonal skills. Effective oral & written communication skills.
* Ability to effectively represent Biostatistics and Clinical Data Management in multidisciplinary meetings.
* Demonstrated ability to complete complex tasks on a timely basis with minimal supervision; well organized.
* Good project management skills.
* Good team player, good business ethics
For a confidential consultation call Laura Christie on +44 207 633 4825 or email your CV to [log in to unmask]
I look forward to hearing from you.
Kind regards,
Laura
Laura Christie
Team Leader, Biometrics & HEOR, Europe
Recruiting experts in Life Sciences
HAYS Recruiting experts worldwide
25-27 Wootton Street
London
SE1 8TG
T: +44 207 633 4825
M: +44 7900 932031
F: +44 207 922 7101
E: [log in to unmask]<mailto:[log in to unmask]>
http://uk.linkedin.com/pub/laura-christie/18/492/6b9
hays.co.uk
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