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Description

Provide operational oversight for all IIS/TS deliverables for assigned projects and studies, including full responsibility for timelines and quality standards. Scope of projects may include those in very early phases of development leading up to a proof of concept (PoC), but also the TS aspects of late phase projects and submissions.

Provide scientific input and advise to project and study teams, and provide guidance and leadership with respect to innovative approaches to study design and decision making; ensure appropriate involvements of M&S, Statistical Methodology and other internal or external statistical consultants in all assigned projects.

Contribute to Clinical Development Plans for assigned projects.

Partner with the project and study teams, and represent Biostatistics in review and decision boards such as protocol review committee and PoC peer review.

Be accountable to the TA (Therapeutic Area) lead statistician in the respective TA and to the global head of Scientific Support in IIS/TS for timeliness and high quality of all IIS/TS deliverables in assigned projects.

Interact with Health Authorities and external consultants and experts as appropriate.

Support evaluation of in-licensing opportunities as appropriate. Minimum requirements University degree in Statistics or Mathematics (Ph.D. or MSc. Level)
At least five years of relevant experience in the field of clinical trials
Strong statistical skills and knowledge of clinical trials methodology
fluent in English, written and spoken
Experience gained in all main tasks of a Senior Statistician, and experience as project statistician for international clinical teams or comparable experience in similar ED role.
Good leadership skills.
Very good project management skills.
Very good communication and presentation skills
Good knowledge of the drug development process and relevant HA guidelines.
Basic coaching and mentoring skills.
Good team player.
Strong knowledge and expertise in statistics and its applications in clinical trials.
Experience with implementation of novel methods and/or innovative strategies

Details:

Job Id: 23685223

Posted / Updated: 4/21/2012 3:38:40 AM

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