Associate Director, Biostatistics - Early RIA

  • AstraZeneca
  • Cambridge CB2 8PA, UK
  • 08/08/2020
Full time Data Science Big Data Statistics Biostatistics

Job Description

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 Principal Statistician sits within our Early Biometrics groups in EB&SI, aligned either to Cardiovascular/Renal/Metabolism (CVRM) or Respiratory, Inflammation, and Autoimmunity (RIA) and is responsible for providing statistical expertise to support the design and interpretation of early clinical studies, regulatory submissions and the development programmes for our compounds, including collaboration with Late Biometrics groups in CVRM and RIA.

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 develop new statistical ideas and approaches, and to apply them in your work.

Main duties and responsibilities

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 Organizations 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.

Requirements

Essential

  • Bachelor's Degree in Statistics, Biostatistics, or related quantitative fields, or equivalent course work/ technical experience
  • Understanding of regulations/developments in the area of Clinical Development and Biostatistics
  • Appropriate experience as a statistician for the relevant position level with clinical trials, pharmaceutical development, regulated research, and/or related areas of statistical applications
  • A collaborative mindset
  • A general dedication to and ability to apply expertise to problem solving
  • Experience with relevant statistical software
  • Ability to apply statistical techniques in the analysis of data from clinical studies or other significant area

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 great fit, please share this posting with them.