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    Senior Regulatory Re - Cambridge, Cambridgeshire, United Kingdom - AL Solutions

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    Description
    George Higginson is currently searching for a highly experienced Senior Biostatistician for a clinical-stage Biotech, specialising in Dermatology/Rheumatology.

    As a Senior Biostatistician, you are responsible for the oversight and management of biostatistics activities to ensure high quality design, analysis and interpretation of sponsored clinical trials.

    Statistical contribution to the design, analysis and interpretation of clinical studies, including the writing the statistical sections of protocols, SAPs and study related activities.

    Oversight and review of vendor statistical activities, with accountability for study level timeliness and quality of statistical deliveries.
    Provide statistical insight and exploratory analyses of completed and ongoing studies.

    Provide effective communication and visualisation of data and statistical analyses within our company and support for publications and presentations.

    Communicate progress and identify risks and issues arising on clinical trials to the Director of Clinical Operations and other development team members as appropriate.

    Postgraduate degree in statistics or related discipline.
    Substantial experience of clinical biostatistics in the pharmaceutical/biotech industry.

    Robust knowledge of GCP and related regulatory standards for clinical biostatistics governing clinical trials in the UK, EU & USA.

    Programming experience with SAS and/or R.
    Ability to interpret, process and present data in innovative ways to meet the needs of multiple stakeholders.

    Influencer with ability to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors including CROs and consultants.

    Ability to see complex projects to completion, and to work on a broad range of tasks within a project.

    We place professionals across the UK, Europe, the United States and Canada for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

    If this position doesn't interest you, please visit our website for a list of more vacancies.


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