• Biostatistician (Consultant)

    Job Locations US-NJ-Jersey City
    ID
    2018-1182
    # of Openings
    1
    Category
    Clinical Development
  • Overview

    Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

     

    Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.

     

    The Consultant Biostatistician is responsible for advising on, contributing to, as well as developing and implementing statistical solutions that will optimally support all phases of clinical trials and decision making in all areas of clinical development, including the rare disease setting. The successful candidate will be accountable for designated statistical deliverables. The role will include typical responsibilities of the principal statistician including statistical design of all phases of trials, authoring of SAPs, and conducting just-in-time analyses and data exploration.

     

    This is a need-based statistical consultant position.  The average number of working hours will be between 20 to 40 hours per month.

    Responsibilities

    • Serve as statistical expert for clinical development for all biostatistics aspects
    • Ensure that clinical trials meet scientific, regulatory, and quality requirements
    • Propose and apply innovative statistical methods and approaches to study design, analysis and data exploration, including Bayesian adaptive methods such as the adaptive dose finding etc
    • Provide statistical expertise in regulatory submission activities, such as SCS, SCE, briefing books
    • Provide statistical support for regulatory documents and attend regulatory meetings (FDA, EMEA)
    • Provide statistical expert support in statistical analysis methods for integrated summary of safety and effectiveness (ISS/ISE)
    • Provide statistical expert support addressing FDA inquiries and questions for the IND/NDA
    • Provide statistical expert support in preparing statistical analysis for FDA advisory committee meetings
    • At the FDA advisory meeting, present and interpret the statistical analysis for the NDA

    Qualifications

    • Doctor of Philosophy (PhD) degree
    • Minimum 10 years of biopharmaceutical industry or equivalent experience
    • Proven expertise in statistics and its applications to clinical trials
    • FDA Advisory meeting attendance/participation experience required
    • Strong background in statistical analysis methodology and extensive experience in statistical analysis for clinical studies
    • Extensive experience with IND, NDA and FDA advisory committee meetings
    • Fluent in statistical software including SAS, R, EAST packages, among others
    • Excellent communication skills; fluent oral/written English
    • Strong presentation skills
    • Innovative, flexible mindset

    Preferred Expertise:

    • Rare disease and/or orphan drug prior experience and understanding of how to structure and craft statistical models evaluating small databases
    • Prior program/principal statistician roles
    • Diverse study design and statistical simulation experience

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