Associate Director I/II, Real World Data Statistics
BengaluruFull-time10–18 yrsPosted 2 days ago
Leadership finance role at Alexion (AstraZeneca Rare Disease) in Bengaluru. Needs 10+ years and a PhD.
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
- Statistics
- Reporting
- Regulatory affairs
- Compliance
- Audit
- SAS
Good to have
- SQL
- R
- Python
- Biology