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Statistical Science Associate Director - Late CVRM

Location Gaithersburg, Maryland, United States Durham, North Carolina, United States Job ID R-098149 Date posted 27/09/2021

Statistical Science Associate Director – Late Cardiovascular, Renal and Metabolism (CVRM)

Location: Gaithersburg or Durham (US)

Competitive salary and benefits

Play a critical role in making our pipeline accessible to patients.

Do you have expertise in, and passion for, Biostatistics? Would you like to apply your skills to impact the early phase of drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.

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.

The Statistical Science Associate Director is responsible for providing statistical expertise to support the development programs for our compounds, including collaboration with other Biometrics groups, 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 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 channelling our scientific capabilities to make a positive impact on changing patients' lives.

The Statistical Science Associate Director 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 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 CVRM.
  • 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

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 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

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants.  COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.

So, what’s next?

  • Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
  • Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

Where can I find out more?

Date advert opened: 13th July 2021

Date advert closed for applications: 13th August 2021



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.

50056349 E CDBT R&D BioPharmaceuticals

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.