[Next-Generation Sequencing Book]
  • [Photo] Human Resource • November 24, 2008
    REQUIREMENTS:
    • Ph.D. in statistics, biostatistics or biometry, with at least 6 years experience in pharmaceutical clinical trial experience, preferably in the pharmaceutical industry and/or Regulatory Authorities, or M.S. in the above mentioned areas with 10 years of similar experience.
    • Ability to successfully plan and conduct a submission project, including interactions with regulatory authorities on statistical issues.
    • Ability to challenge methodological issues
    • Ability to supervise scientific/technical work
    • Excellent interpersonal skills with the ability to interact effectively with people, internally and externally (e.g., Contract Research Organizations, experts, management)
    • Must have excellent oral and written presentation skills
    • Record of publications (as joint author) in clinical trials.
    • Sound knowledge of statistical methodology; ability to critique devised hypotheses and results interpretation.
    • Demonstrated ability to work successfully on international project teams
    DUTIES & RESPONSIBILITIES:
    • Perform duties of a Project or Trial Statistician to support high-profile international clinical development projects/trials or marketed products as required.
    • Provide statistical input into the creation of clinical development plans and/or marketing and publication strategies. Assure well-designed clinical trials.
    • Provide statistical expertise necessary to design, analyze, interpret and communicate the results of major, prototypical clinical trials, and substantiate new efficacy and safety claims.
    • Take on the key statistical responsibility in the planning and preparation of regulatory submissions.
    • Represent the company as required before regulatory agencies and other organizations in defense of statistical methodologies and data analyses related to our products.
      • - Serve on internal Data Monitoring Committees (DMCs) or represent the company on external DMCs. Publish methodological research based on projects at BI.

HOW TO APPLY

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Discussion forums: Opportunity: Senior Principal BIOSTATISTICIAN @ Boehringer Ingelheim--Danbury/Bridgeport, CT (US)

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