Alexion
Rare Disease Biopharma
RealWorldDataStatisticianI/II
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Real World Data Statistician I/II at Alexion. Skills: statistics, real-world evidence, registry data analysis, regulatory compliance. 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; advancing patient therapies; inform regulatory submissions; evidence generation for scientific publications; fulfilling post-market commitments; meet global regulatory expectations; elevate practice through shared findings; ensure methodological rigor and consistent data quality; drive reproducibility, audit readiness, and transparent reporting; emphasize clinical impact; align with regulatory strategy and meet health authority expectations; ensure compliance with FDA Real-World Evidence Framework, EMA guidance on registry-based studies, and regulatory guidance documents; meet regulatory standards; ensure methodological rigor and alignment with regulatory requirements; advances therapies for people with rare diseases
Industry & Context.
addressing challenges such as missingness, data linkage, confounding, and outcome
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
support the generation of real-world evidence from disease registries and observational data
apply foundational statistical methods
develop registry-specific analytical approaches
assist in delivering 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
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; regulatory interactions and advisory meetings; collaborating with external registry investigators, statisticians, and regulatory consultants; collaborate across disciplines
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
Full Job Description
**Job Title: Real World Data Statistician I/II** **Global Career Level: C1/C2** **Role: Individual contributor role** **Location: Manyata Tech Park, Bangalore** **About Alexion** At Alexion, our mission is to transform the lives of people affected by rare diseases through the development and delivery of innovative medicines as well as supportive technologies and healthcare services. **Introduction to role:** Are you passionate about statistics, real-world evidence, and their application in advancing patient therapies? This is an excellent opportunity at the intersection of statistics and real world evidence generation. You will support the generation of real-world evidence from disease registries and observational data, contributing to analyses that inform regulatory submissions, evidence generation for scientific publications, and fulfilling post-market commitments. Can you envision transforming registry data into meaningful insights that meet health authority standards? Joining our epidemiology and real-world evidence team, you will apply foundational statistical methods, develop registry-specific analytical approaches, and contribute to projects that demand rigor, curiosity, and attention to detail. **Accountabilities:** Registry Evidence Strategy: Assist in delivering analytical strategies for registry-based evidence, crafting regulatory submissions and decisions across rare disease programs. Regulatory-Grade Analyses: Support the design, implementation, and validation of survival, causal inference, propensity score, and longitudinal models tailored for registry data; support analyses that meet global regulatory expectations. Methodological Innovation: Support the development and documentation of robust, registry-specific statistical approaches addressing challenges such as missingness, data linkage, confounding, and outcome validation; elevate practice through shared findings. Cross-Functional and External Collaboration: Participate in collaborations with clini
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