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Hi Allstat,

I hope you are all well.

Introducing the PHARMA CONSULTING GROUP

Please find below our latest permanent vacancy to be based in Germany


Lead Biostatistician

Germany

Office based with possibility of HW

Permanent

Competitive salary


Responsibilities:

*         As member of project team, ensure that clinical development program meets scientific, regulatory, quality and commercialization requirements.

*         Act as leader for all biostats deliverables for a clinical development project, including the coordination and supervision of trial biostatisticians allocated to the project as well as insuring that methodological and operational experts are involved as appropriate and needed for the project.

*         Act as project manager for all the statistical deliverables for a clinical development project, including the planning and tracking of project level activities, including resource management, planning and managing submission activities.

*         Set the strategic direction for addressing statistical issues in regulatory submissions, and directly influence drug development decisions with internal and external partners. Drives and coordinates the quantitative approach to decision making process at development milestone.

*         Implement state-of-the-art and innovative trial designs, statistical models, and analysis methodologies that optimize the drug development program. Insure full integration of modern quantitative aspects of drug development.

*         Establish and maintain project standards, project SAP including the development of ISS/ISE.

*         Responsible for successful interactions with Health Authorities, Pricing and Reimbursement agencies. Plan and manage submission activities. Represent biostatistics in these meetings.

 *   Oversee vendors and set up collaborations with scientific experts.

*         Could take Trial Statistician responsibility as appropriate.

Your profile:

*         PhD or MSc in Statistics or related topics

*         Minimum 6/7 yrs of industry experience & must have project biostatistician exp

 *   Solid knowledge of statistical methods & techniques extensive knowledge of drug development processes

*         Excellent verbal and written English language skills

*         Knowledge of statistical software packages (e.g. SAS, S+)

*         Good leadership skills & the ability to give effective guidance to other members of the Biometrics team


For a confidential consultation call Laura Christie  on +44 203 627 8319 or email your CV to [log in to unmask]<mailto:[log in to unmask]>
I look forward to hearing from you.
Kind regards,
Laura




Laura Christie

European Biometrics Manager

Pharma Consulting Group Ltd

DDI:

020 3627 8319

20 St Dunstan's Hill

Tel:

020 3627 8300

London, EC3R 8HY





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Pharma Consulting Group Ltd incorporates Fforde & CSL

This transmission has been issued by Pharma Consulting Group for the information of the addressee only and should not be reproduced and / or distributed to any other person. Unless otherwise agreed in writing, any CV or Candidate details hereto must be read in conjunction with, and are subject to, Pharma Consulting Group's Standard Terms of Business. Its contents are based on information obtained from sources believed to be reliable but Pharma Consulting Group makes no representation and accepts no responsibility or liability as to its completeness or accuracy.
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