Alexion
Rare Disease Biopharma
RealWorldDataStatisticianI/II
“Real World Data Statistician I/II at Alexion. Skills: statistics, real-world evidence, registry data analysis, regulatory-grade analyses, survival analysis, causal inference, propensity score, longitudinal modeling. generation of real-world evidence from disease registries and observational data. analyses that inform regulatory submissions, evidence generation for scientific publications, and fulfilling post-market commitments”
What You'll Achieve.
transforming registry data into meaningful insights that meet health authority standards; drive reproducibility, audit readiness, and transparent reporting in statistical deliverables; advances therapies for people with rare diseases
Industry & Context.
addressing challenges such as missingness, data linkage, confounding, and outcome elevate practice
What They're Looking For.
Must Have
statistics, real-world evidence, foundational statistical methods, registry-specific analytical approaches, survival analysis, causal inference, propensity score, longitudinal models, FDA RWE Framework, EMA registry guidance, statistical reports, clinical study reports (CSRs), regulatory briefing documents, FDA Real-World Evidence Framework, EMA guidance on registry-based studies, regulatory guidance documents, statistical methodologies for real-world evidence generation, SQL, Python
Nice to Have
Peer-reviewed publications or conference presentations in pharmacoepidemiology, methodology, or applied real-world evidence, Practical expertise in data quality assessment, cohort construction, linkage, and missing data strategies for registries, communication skills with the ability to influence collaborators and translate sophisticated methods into clear decisions
What You'll Do.
generation of real-world evidence from disease registries and observational data
analyses that inform regulatory submissions
evidence generation for scientific publications
and fulfilling post-market commitments
transforming registry data into meaningful insights that meet health authority standards
apply foundational statistical methods
develop registry-specific analytical approaches
deliver analytical strategies for registry-based evidence
crafting regulatory submissions and decisions across rare disease programs
and validation of survival
and longitudinal models tailored for registry support analyses
support the development and documentation of robust
registry-specific statistical approaches addressing challenges such as missingness
and outcome elevate practice
participate in collaborations with clinical
and registry operations
participate in engagements with external registry investigators
align with AstraZeneca standard methodologies and guidance
drive reproducibility
and transparent reporting in statistical deliverables
communicate statistical design
and conclusions to cross-functional teams by translating technical findings that emphasize clinical impact
Conduct advanced statistical analyses of data from disease registries
natural history studies
and claims data for regulatory submissions
Support collaborations within registry teams across epidemiology and programming functions
Support Alexion in regulatory interactions and advisory meetings
Support the development of regulatory-quality deliverables including statistical reports
clinical study reports (CSRs)
and regulatory briefing documents based on registry analyses
Support the development and validation of statistical methodologies for real-world evidence generation from registry sources
How You'll Work.
Team & Collaboration
collaborations with clinical, epidemiology, regulatory, and registry operations; collaborations within registry teams across epidemiology and programming functions; collaborations with external registry investigators, statisticians, and regulatory consultants; communicate statistical design, concepts, and conclusions to cross-functional teams
Communication Scope
communicate statistical design, concepts, and conclusions to cross-functional teams; translating technical findings that emphasize clinical impact; communication skills with the ability to influence collaborators and translate sophisticated methods into clear decisions
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