Associate Director of Regulatory Consulting

1 month ago


Mississauga, Canada AstraZeneca Full time
p>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 head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm, and connect on key projects.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.The Statistical Science Associate Director may work as a lead statistician:For a project or indication in clinical or preclinical therapeutic areas Leading the delivery and oversight on multiple studies/indication within a project, potentially as a Global Project Statistician for a standard drug project Accountabilities for Supporting Projects Lead the statistical thinking and contributions to the delivery of studies, development plans, regulatory strategy, health technology assessment, and/or commercial activities Direct project work, including statistical staff and/or CRO partners, to ensure delivery to standards, quality, and time Develop design options and provide high-quality decision support to enable the business to make informed decisions about a study or project Quantify the benefit, risk, value, and uncertainty of the emerging asset/product profile Investigate and apply novel statistical approaches for relevant statistical issues and/or regulatory guidance and/or value demonstration, including modelling and simulation Mentor/coach and support the education and training of statistics staff Accountabilities for Supporting Statistical Methodological Advances Ability to consult across project teams within the area of expertise Application of expert skills to investigate and apply novel statistical approaches for relevant statistical issues and/or regulatory guidance and/or value demonstration, including modelling and simulation Mentor/coach and support the education and training of statistics staff in the technical arena MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognized equivalent to stats MSc Knowledge of the technical and regulatory requirements related to the role Technical Requirements Usually PhD in Statistics or a relevant topic

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 AZCHumanResources@astrazeneca.



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