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    Senior Director of Quality - England, United Kingdom - Warman O'Brien

    Warman O'Brien
    Warman O'Brien England, United Kingdom

    2 weeks ago

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    Description
    Senior Director of Statistics - United Kingdom - Hybrid / Remote - Excellent Remuneration & Benefits

    I am working exclusively for a SME biotech who are looking for a Director of Biostatistics (Senior also considered) to join as a senior member of a cross-functional asset team, reporting to the Chief Development Officer (CDO).

    You will also be responsible for developing trial designs that address study objectives that will support regulatory approval, including contributing to Clinical Development Plans, submissions, and post-submission strategies, preparations, and defences.

    You will provide guidance and management to CRO based statisticians and data scientists to ensure high quality and timely deliverables, whilst managing resources, setting priorities, and ensuring consistency and adherence to standards therein.


    Provide statistical support for clinical studies, including study design, sample size calculations, patient randomization, statistical analyses, interpretation of data, and reporting of results.

    Present and defend complex statistical solutions to all levels of the company's governance, key stakeholders and external regulatory bodies in a clear, concise, complete, and transparent manner that provide influence on key decisions.

    Review/Develop the Statistical Analysis Plan, including the definition of derived data sets, and the design of statistical tables, figures, and data listings for clinical summary reports.

    Plan and conduct statistical analysis (ISS, ISE), post-hoc analyses, exploratory analyses, or analyses requested by regulatory agencies.

    Collaborate in writing regulatory document, reviews sections of regulatory submissions, attends meetings with regulatory agencies to support drug registration.

    Promote, investigate, develop, and implement novel statistical approaches/methodologies, for relevant statistical issues (in collaboration with academic groups, as needed).

    Where appropriate, provide guidance and management to statisticians to ensure high quality and timely deliverables.
    As required, perform ad hoc and exploratory data analyses.
    Where appropriate, provide training, seminars and/or coaching in statistical topics to non-statistical company staff.

    You'll have an entrepreneurial mindset and the ability to bring creative solutions to challenges.

    PhD or MSc in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry or healthcare experience.

    Proficiency in scientific computing/programming (SAS, R or Python) and implementation of advanced statistical analysis, data manipulation, graphing & simulation.
    Excellent interpersonal, communication, writing and organizational skills.

    Demonstratable expertise in applying knowledge of general and cutting edge statistical / clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards.

    Experience in preparing and participating in global regulatory agency interactions.
    Demonstrated people management and leadership (direct or matrix) experience is preferred.

    Significant experience on a full development asset providing statistical guidance and input to the clinical development plan, regulatory Health Authority submissions (NDA/BLA/MAA) and defence and acted as the lead statistician on responding to submission-related questions from Health Authorities.

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