Senior Real World Data Statistician III

Job Title: Senior Real World Data Statistician I/II

Global Career Level: D

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:

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 fulfill 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 Masters 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 clear decisions

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca provides the chance to work at the forefront of rare disease biopharma. Here complex biology and advanced technology come together to compose transformative medicines for individuals with devastating conditions. At Alexion within AstraZeneca Rare Disease work is driven by a deep connection to patients lived experiences and a clear purpose that shapes decisions every day. The environment combines the agility of a biotech with the reach and resources of a global organizationencouraging curiosity transparent science ethical decision-making and continuous learning. Teams collaborate across disciplines to explore rare opportunities in areas of high unmet need while investing in personal growth through tailored development programs that build both technical mastery and empathy for patients journeys.

Call to Action:

Ready to turn registries into regulatory-grade evidence that advances therapies for people with rare diseasesshare your CV and start crafting what comes next!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race religion color national origin sex gender gender expression sexual orientation age marital status veteran status or disability status.

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E-Verify.