Real World Data Statistician III

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 clinical epidemiology regulatory and registry operations teams; participate in engagements with external registry investigators statisticians and consultants to ensure methodological rigor and consistent data quality.

Standards Quality and Compliance: Align 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: Under guidance from senior team members communicate statistical design concepts and conclusions to cross-functional teams by translating technical findings that emphasize clinical impact.

Essential Responsibilities:

• Conduct 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 modeling and registry-specific statistical approaches that align with regulatory guidelines

• Support collaborations within registry teams across epidemiology and programming functions. 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

• Support the development of regulatory-quality deliverables including statistical reports clinical study reports (CSRs) 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.

• Support the development and validation of 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:

• Advanced degree or equivalent experience in statistics biostatistics epidemiology.

• Working knowledge of R and/or SAS for analytics; familiarity with SQL or Python for data engineering and validation

• Experience generating real-world evidence for rare disease programs or patient populations

• 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 offers the chance to work at the forefront of rare disease biopharma where complex biology meets advanced technology to create transformative medicines for people 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 shaping 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.