About The Opportunity Are you passionate about shaping the future of clinical data standards? Alexion, a global leader in pharmaceutical innovation, is looking for an Associate Director, Standards Developer to lead the charge in developing, managing...
About The Opportunity

Are you passionate about shaping the future of clinical data standards? Alexion, a global leader in pharmaceutical innovation, is looking for an Associate Director, Standards Developer to lead the charge in developing, managing, and governing Clinical Data Standards. This pivotal role is not just about maintaining standards; it's about being at the forefront of industry practices, driving quality, and steering the evolution of clinical data management.

Your Impact

As the Associate Director, Standards Developer, you will:

  • Lead and Innovate: Take charge of clinical data standards projects, influencing the methodologies that underpin groundbreaking clinical research.
  • Be the Expert: Harness your technical expertise in raw data standards, including data collection and cleaning components, as well as clinical coding dictionaries.
  • Manage Excellence: Oversee the activities of CRO and external partners, ensuring the highest quality standards are upheld in every deliverable.
  • Drive Best Practices: Identify and implement opportunities to refine processes, contributing to the development of best practices within the function.
  • Strategize and Implement: Provide strategic input and lead the execution of standards strategies to meet dynamic internal and external demands.
  • Govern and Guide: Lead standards governance, contribute to industry standards groups, and ensure adherence to best practices across the board.

Who You Are

Essential Qualifications:

  • BSc in Information Sciences, Mathematical, Statistical, Computer Science, Life Science, or equivalent experience.
  • Proven expertise in specialized standards development skills, with an emphasis on raw data standards and clinical coding dictionaries.
  • Excellent knowledge of industry standards such as CDASH, SDTM, ADaM, and a knack for problem-solving with these tools.
  • Exceptional communication skills in English, both written and spoken.
  • Strong project management capabilities and experience mentoring, training, and leading teams.
  • Comprehensive understanding of the clinical development process and a commitment to truth-seeking behaviors.
  • Agility to respond to industry and business needs, with a welcoming attitude towards peer review.

Desirable Qualifications:

  • Familiarity with Formedix ryze.
  • Ability to influence stakeholders on standards-related items and manage risks effectively.
  • Experience in line management and contributing to external standards groups.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

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 authorization and employment eligibility verification requirements

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