Associate Director I/II, Real World Data Statistics

About the role

Associate Director I/II, Real World Data Statistics at Alexion (AstraZeneca Rare Disease). Registry Evidence Strategy: Oversee the statistical vision and analytical strategies for registry-based evidence.

What you'll do

• Standards, Quality, and Compliance: Lead and ensure alignment with AstraZeneca standard methodologies and guidance (e.g., FDA RWE Framework, EMA registry guidance)
• People Leadership and Capability Building: Serve as a mentor and coach to other Real World Data Statisticians within the team
• Lead and oversee the design and implementation of advanced statistical analyses of data from disease registries, patient registries, natural history studies, EMR
• Drive cross-functional collaboration, partnering with registry teams in regulatory interactions and advisory meetings
• Oversee the development of regulatory-quality deliverables including statistical analysis plans, tables/figures/listings

What you need

• 10–18 yrs of experience
• Statistics
• Reporting
• Regulatory affairs
• Compliance
• Audit
• SAS
• PhD

Good to have

• SQL
• R
• Python
• Biology