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Statistical Science Director (Hybrid)

AstraZeneca GmbH
Waltham, Massachusetts, US
Full-time

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work.

We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

AstraZeneca is a global, BioPharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases.

Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world’s most complex diseases.

Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

We work on some of the most complex and interesting challenges. 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.

You will join a global, diverse and cross-functional environment where you will get personal and professional development.

We are recruiting a Statistical Science Director to join our growing Statistical Innovation team. Our main focus is providing statistical methodology support for all phases of clinical development for AZ’s Cardiovascular, Renal & Metabolism, Respiratory & Immunology, and Vaccine and Immune Therapies divisions together with specific targeted support for the Oncology division and the Rare Disease unit of AZ.

In this role, you will be a member of the Statistical Innovation team, where our data-centric focus helps us work efficiently and creatively to bring the right medicines to the right patients.

What You'll Do :

Joining a team of statistical methodology experts, you will provide key input as you work to find solutions to problems at critical stages in the drug development cycle.

This is exciting and technically challenging work in a dynamic and constantly changing landscape. Your key focus will be on producing pragmatic solutions, often within a tight time scale where the emphasis will be to deliver first, then refine and develop your solutions thereafter.

You will lead the development of methodology in one or more of the following statistical areas :

  • Design of early and late phase clinical studies : including group sequential and adaptive designs using both frequentist and Bayesian approaches including simulating operating characteristics of different design options.
  • Methods to analyse data collected in real-time, Estimands, Missing Data, Subgroup and Biomarkers.
  • Develop external networks, as well as building and maintaining existing networks, with academics and peers from other pharma companies as well as establishing an internal network of statisticians who can drive forward innovation in these areas.
  • You will be involved in developing and implementing new methodology, interacting with external scientists and regulators, through publications, presentations and cross-industry collaborations.
  • You will also work with others internally to develop and implement internal guidance to make this new methodology business as usual within Biometrics at AstraZeneca.
  • There will also be an expectation to proactively identify new areas where Statistical Innovation can contribute, developing collaborative relationships with the external scientific / academic community.

Essential for the role :

  • PhD in Statistics or related area with 10+ years of relevant experience.
  • Extensive experience of independent academic research and clinical drug development including broad knowledge of statistical methodology use in the design and analysis of early and late Phase clinical trials.
  • Solid understanding of programming in R and / or SAS.
  • An urge to apply your scientific competence on practical problems, for the benefit of patients.
  • An extensive track record of research and methodological development in clinical trials supported by scientific publications and presentations at conferences.
  • Broad awareness of current statistical issues being debated by regulatory authorities.
  • International reputation as a leading researcher in the development of statistical methodology applied to Phase II and / or Phase III clinical trials in more than one of the following areas :
  • Analysis and interpretation of safety data
  • Subgroup analysis
  • Missing data
  • Estimands
  • Bayesian Dynamic Borrowing
  • Causal inference
  • Design of clinical trials including comprehensive knowledge and application of multiplicity testing procedures.

Are you interested in working at AZ? Apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination.

AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing [email protected].

Ensure you read the information regarding this opportunity thoroughly before making an application.

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Remote working / work at home options are available for this role.

10 days ago
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