Oxford Immunotec, Inc.

  • Statistician - R&D and Clinical trials

    Job Locations UK-Milton Park, Abindgon
    Posted Date 1 month ago(21/05/2018 2:04 PM)
    ID
    2018-1915
    # of Openings
    1
    Department
    Development
  • Overview

    This position is a key member of the Product Development Team and is specifically responsible the pre-clinical and post launch statistical analysis. The post holder will also be part of the Development team and be responsible for the performance and interpretation of experimental data in support of Oxford Immunotec’s product development.

     

    Overall responsibilities:

     

    1. Generation of statistical analysis plans and execution of analysis
    2. Working closely with Product Development Manager, to assist with the project management and/or workstream management
    3. Critical assessment of study designs and conduct of complex investigations
    4. ODL routine testing laboratory authoriser of results.

    Primary Responsibilities

    • Implementing best practices for experimental design & statistical analysis across the research and development group.
    • Contributing to protocols and study plans
    • Producing & delivering statistical analysis and reports for our clinical, medical affairs and product development teams.
    • Liaise with CROs/external collaborators and present statistical findings to workstream groups
    • Contribute statistical analysis to regulatory submissions
    • Providing statistical training & development for staff
    • Assisting with the leadership of projects and/or workstreams as required.
    • Preparing detailed project plans in line with overall Oxford Immunotec strategy.
    • Supervising Scientists as required.
    • Prioritising workload to ensure key objectives agreed with Senior Development Manager are met on time and to budget.
    • Identifying new opportunities to assist project completion or for new projects and/or applications of current technology.
    • Presenting Oxford Immunotec data to external collaborators and at International Symposia as required.
    • Ensuring that supervisor(s) are fully briefed in good time when a project is running behind schedule and/or over budget.
    • Ensuring that conclusions in reports written reflect the data presented and reports are of the highest quality.
    • Ensuring that projects are carried out in accordance with the Company Quality System and to the required Regulatory standards.
    • As authoriser in the ODL business ensuring that all work is performed under ISO 17025:2005.

    Work to Oxford Immunotec Company Values at all times

    Qualifications

    PROFILE OF THE CANDIDATE

    Desirable Technical skills and abilities

    • Strong expertise in Statistics applicable to clinical trials and scientific studies.
    • An understanding of the diagnostic and pharmaceutical industries
    • Familiarity with Quality System concepts and requirements including GMP and ISO systems.
    • Strong statistical analysis and reporting skills
    • Understanding of data life cycle for data from product development to registration of regulated products
    • Leadership skills & communication skills
    • Experience across a broad spectrum of R&D including pre-clinical, medical affairs and product developmen

    Essential Technical skills and abilities

    • Knowledge of Statistical Analysis data packages, Windows and Office bases applications; Word, Excel, PowerPoint.
    • At least a PhD or MSc in a life sciences subject, preferably Biotechnology, Biochemistry, Immunology or Biology
    • Previous experience in immunological assays, T cell activation assays, Elisa, PCR, cell assays, cell cultures

     

    Emotional skills and abilities

    • Capable of handling multiple tasks at the same time.
    • Capable of working effectively in a team environment.
    • Able to communicate effectively at all levels.

     

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