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    Director Regulatory Science - Macclesfield, Cheshire, United Kingdom - myGwork

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    Description
    Statistical Science Director - Early Oncology
    Competitive salary and benefits
    We are open to discussing working part-time (min 0.Would you like to apply your skills to impact all phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. A fast-paced and agile team, we are empowered and trusted to innovate and experiment.

    With access to our extensive capabilities and comprehensive pipeline, you'll be involved in countless submissions and a wide range of engaging projects along the complete drug development process.

    In this role you will be responsible in leading the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within an AZ product team.

    You will provide leadership to statistical staff on the indications/projects so that all work is carried out with regards to AZ standards and external regulations; through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions; quantifying the benefit, risk, value and uncertainty of the emerging product profile.

    You will be holding CRO/Partners accountable for the high quality standards of their deliverables. You will represent AZ and Statistics to Health Authorities and Reimbursement/Payer Organisations for specific projects/indications.

    You will apply expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.

    You will mentor/coach and support the education and training of Statistics staff in the technical arena.
    MSc or PhD degree in Statistics, Biostatistics, or related quantitative fields, or equivalent course work/technical experience
    # Appropriate experience as a statistician for the relevant position level with clinical trials, pharmaceutical development, regulated research, and/or related areas of statistical applications
    # Experience with relevant statistical software
    # Ability to apply statistical techniques in the analysis of data from clinical studies or other significant areas

    Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. Our Social Media, Follow AstraZeneca on LinkedIn
    # Follow AstraZeneca on Facebook
    # Follow AstraZeneca on Instagram


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