Principal Statistician/Associate Director - Early R&I

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.

We are currently looking for an experienced Principal/Associate Director Statistician to work at the heart of our early-phase clinical project teams. Your proven statistical expertise will be a key influence on our clinical programme designs, informing our decision making and driving best practice.

The Principal Statistician/Associate Director of Statistics sits within our Early Biometrics groups in EB&SI, aligned to Respiratory & Immunology (R&I), 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 clincial trial reseach.



Main duties and responsibilities

Joining a team of statistical and programming experts working in early clinical development, you will be expected to provide strategic direction as you work to bring robust quantitative thinking to the drug development cycle. You'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.

The Principal Statistician/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 will also 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 best practice.

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 stakeholders and governance

Essential Requirements

* 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 communication skills and ability to build strong relationships
* Excellent 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



We would like to know more about you. If you are interested, Apply today!



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