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Associate Director, Statistics - Early RIA

Plats Gaithersburg, Maryland, USA Cambridge, England, Storbritannien Jobb-id R-062569 Datum inlagd 10/02/2019

Associate Director, Statistics for early clinical trials in BioPharmaceuticals R&D

Location – Cambridge/ Gaithersburg/ Gothenburg

Would you like to be a part of a Biostatistical group, who has direct strategic impact on drug development, playing a key role in getting medicines to patients?

At AstraZeneca we’re driving leading-edge approaches to drug development across many business areas – within Early Biometrics & Statistical Innovation (EB&SI) a data-centric focus is helping us work more efficiently and creatively to bring the right medicines to the right patients. Our biometrics teams use their expertise in statistics and programming to answer drug development objectives and reduce uncertainty in product development, driving better business decisions with quantitative reasoning.

The Associate Director of Statistics sits within our Early Biometrics groups in EB&SI, aligned to Respiratory, Inflammation, and Autoimmunity (RIA), and is responsible for providing statistical expertise to support the development programs for our compounds, including collaboration with Late Biometrics groups in RIA, along with contributions to the design and interpretation of early clinical studies and related regulatory interactions.

Working as part of Data Science and AI, you’ll be able to access technology at the forefront of science in a creative environment, where you will have the scope to shape the way we work and develop new statistical ideas and approaches applied in early clinical trial research.

Main duties and responsibilities

Joining a team of statistical and programming experts working in early clinical development, you will be encouraged to provide strategic direction as you work to bring robust quantitative thinking to the drug development cycle.

The Associate Director of Statistics will provide leadership on the project and portfolio level, bringing statistical expertise to the design, analysis, and interpretation of early phase clinical studies, and positioning the early development program to provide clear and actionable evidence for program level decision-making including late development study design. You also will provide support to regulatory submissions including specification of overview documents and response to regulatory questions. Additionally, you will provide leadership to diverse initiatives to drive scientific innovation and standard methodology.

In addition to the above, you will

  • Contribute to the development, sharing and statistical support of new procedures, standards, tools, or techniques to surpass quality, efficiency, and effectiveness within EB&SI.
  • Build opportunities for the application of modelling and simulation to improve study design, methodology and solutions for clinical development, and statistical methodology to improve and provide practical solutions for research/ production activities
  • Coach more junior staff and support with education and training of statistics staff
  • Interact with and influence key partners and governance

Requirements

Essential

  • MSc or PhD degree in Statistics, Biostatistics, or related quantitative fields, or equivalent course work/ technical experience with experience in pharma/healthcare or other relevant area
  • In depth knowledge of the technical and regulatory requirements related to the role
  • Extensive experience of pharmaceutical development, program design and data analysis and interpretation
  • Experience of major regulatory interactions and/or submissions
  • Excellent interpersonal skills and ability to build positive relationships
  • Strong collaboration required – needs the energy to work across global & functional boundaries both internally and externally
  • Ability to apply statistical expertise to complex problems, problem solving and quality focus

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a phenomenal fit, please share this posting with them.

AZRespi #GMD



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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