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Job Title: Expert Statistician
Job Location: NJ: Livingston
Pay Rate: Open
Job Length: full time
Start Date: 2008-09-19

Company Name: The Cambridge Group Ltd.
Contact: Stephanie Oscar
Phone: E-mail or fax only
Fax: 203-226-3856

Description: The Expert Statistician will assume the role of an independent Program Statistician for the assigned clinical development projects, or a mega trial. He/She will be the statistical leader and project for all CIS deliverables globally for: a clinical development program, or a mega trial; ensure that clinical development program (or parts assigned) meets scientific, regulatory, quality, and commercialization requirements, through interaction with the IPT and ICT; perform matrix management of the CIS project team, and mentor staff as required. Additional key responsibilities include: ensuring ECD-BIOS, and modeling and simulation contribution is fully integrated into the project; planning and tracking project level activities for CIS, including resources; establishing and maintaining project standards (master analysis plan, full development project specifications); planning and managing submission activities, like SCS, SCE, briefing books; and participating in/lead non-clinical project activities. The successful candidate will also 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; and may possibly handle Trial Statistician responsibility as appropriate. A MS and 7 years of experience or a PhD with 4 years are required. The qualified individual will also possess: fluency in English (both oral and written); experience gained in the main tasks of a program statistician (about 2 to 4 years); proven knowledge and expertise in statistics and its applications to clinical trials in at least one TA; solid knowledge and experience in drug development process and HA guidelines; background medical knowledge, preferably in relation to the specific therapeutic area; good knowledge of statistical software packages; and very good project management skills. In addition the Expert Statistician will have excellent communication and presentation skills; the ability to give effective guidance to Trial Statisticians and Program Programmer; be a good team player, practice good business ethics and display strong leadership skills.

Please refer to Job code TV5734 when responding to this ad.

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