Job Summary

Role: Individual contributor role

Location: Manyata Tech Park, Bangalore.

Role overview

Introduction to role: Do you thrive at the intersection of statistics, real-world evidence, and regulatory science Step into a role where your expertise in disease registries and longitudinal observational cohorts directly advances therapies for patients. You will craft regulatory-grade evidence from real-world data, guiding submissions that can speed approvals, support label expansions, and fulfil post-market commitments.

Can you envision turning registry data into decisive insights that withstand health authority scrutiny Joining our growing epidemiology and real-world evidence capability, you will apply statistical methodologies tailored for registries, align to AstraZeneca standards, and contribute to a portfolio that demands rigor, creativity, and impact.

Accountabilities

- Registry Evidence Strategy: Define and deliver analytical strategies for registry-based evidence, crafting regulatory submissions and decisions across rare disease programs.
- Regulatory-Grade Analyses: Lead design, implementation, and validation of models tailored for registry data; produce analyses that meet global regulatory expectations.
- Methodological Innovation: Develop and document robust, registry-specific statistical approaches using programming techniques where required for addressing challenges such as missingness, data linkage, confounding, and outcome validation; elevate practice through shared findings. Interpret methodologies like survival, causal inference, propensity score, and longitudinal models to meet research questions from the medical perspectives.
- Cross-Functional and External Collaboration: Partner with clinical, epidemiology, regulatory,



and registry operations teams; engage with external registry investigators, statisticians, and consultants to ensure methodological rigor and consistent data quality.
- Standards, Quality, and Compliance: Ensure alignment with AstraZeneca standard methodologies and guidance (e.g., FDA RWE Framework, EMA registry guidance); drive reproducibility, audit readiness, and transparent reporting in statistical deliverables.
- Communication and Influence: Translate analytical results into narratives for advisory meetings, briefing documents, and study reports, influencing collaborators and regulatory interactions.

Essential Responsibilities

- Develop and implement advanced statistical analyses of data from disease registries, patient registries, natural history studies, EMR, and claims data for regulatory submissions, including survival analysis, inference methods, propensity score matching, longitudinal modelling, and registry-specific statistical approaches that align with regulatory guidelines
- Collaborate directly with registry teams and support Alexion in regulatory interactions and advisory meetings, ensuring registry-derived analyses align with regulatory strategy and meet health authority expectations for FDA, EMA, and other global regulatory submissions
- Prepare and support regulatory-quality deliverables including statistical analysis plans, analysis specifications, tables/figures/listings, and regulatory briefing documents based on registry analyses,



ensuring compliance with FDA Real-World Evidence Framework, EMA guidance on registry-based studies, and regulatory guidance documents
- Develop and validate statistical methodologies for real-world evidence generation from registry sources that meet regulatory standards, while collaborating with external registry investigators, statisticians, and regulatory consultants to ensure methodological rigor and alignment with regulatory requirements

Desirable Skills/Experience

- PhD degree with minimum 4 years of relevant industry experience, or Master s degree with minimum 6 years of relevant industry experience .
- Advanced degree or equivalent experience in statistics, biostatistics, epidemiology.
- Hands-on proficiency with R and/or SAS for analytics; solid understanding of SQL or Python for data engineering and validation
- Demonstrated experience generating real-world evidence for rare disease programs or patient populations
- Track record of contributing to regulatory submissions using registry-based analyses and presenting in health authority or advisory settings
- 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
- Strong communication skills with the ability to influence collaborators and translate sophisticated methods into explicit decisions

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Real World Data Statistician professional (Bengaluru)
🏢 Alexion Pharmaceuticals
📍 Bengaluru