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Associate Director, Standards Development

2 months ago

Mississauga, Canada Alexion Pharmaceuticals,Inc. Full time

Location: Mississauga, Canada; Barcelona, Spain; Dublin, Ireland

Job reference: R-195877

Date posted: 03/26/2024

**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.

LI-Hybrid

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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