Associate Director III, Real World Data Statistics

Job Title: Associate Director I/II Real World Data Statistics

Global Career Level: E

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 lead the development of 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: Oversee the statistical vision and analytical strategies for registry-based evidence crafting regulatory submissions and decisions across rare disease programs.

Regulatory-Grade Analyses: Oversee the design implementation and validation of survival causal inference propensity score and longitudinal models tailored for registry data; produce analyses that meet global regulatory expectations.

Methodological Innovation: Define program and implement 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: Provide leadership to clinical epidemiology regulatory and registry operations teams; represent Alexion in external forums advisory boards and regulatory discussions.

Standards Quality and Compliance: Lead and ensure alignment with AstraZeneca standard methodologies and guidance (e.g. FDA RWE Framework EMA registry guidance); ensure reproducibility audit readiness and transparent reporting in statistical deliverables.

Communication and Influence: Translate analytical results into narratives for executive leadership briefing documents and regulatory submissions creating influence at the program level.

People Leadership and Capability Building: Serve as a mentor and coach to other Real World Data Statisticians within the team; build capability through knowledge-sharing code review and career development guidance.

Essential Responsibilities:

• Lead and oversee the design and implementation of 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

• Drive cross-functional collaboration partnering with registry teams 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

• Oversee the development of regulatory-quality deliverables including statistical analysis plans 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

• Oversee the development and validation of statistical methodologies for real-world evidence generation from registry sources that meet regulatory standards while leading the engagements with external registry investigators statisticians and regulatory consultants to ensure methodological rigor and alignment with regulatory requirements

• Mentor guide and support the professional development of other Real World Data Statisticians within the epidemiology team building a high-performing technically excellent function.

Desirable Skills/Experience:

• PhD degree with minimum 7 years of relevant industry experience or Masters degree with minimum 10 years of relevant industry experience .

• Advanced degree or equivalent experience in statistics biostatistics epidemiology.

• Expert proficiency with R and/or SAS for analytics; solid understanding of SQL or Python for data engineering and validation

• Proven track record of generating real-world evidence for rare disease programs or patient populations

• Demonstrated ability of leading regulatory submissions using registry-based analyses and presenting in health authority or advisory settings

• Leadership in peer-reviewed publications or conference presentations in pharmacoepidemiology methodology or applied real-world evidence

• Extensive expertise in data quality assessment cohort construction linkage and missing data strategies for registries

• Outstanding communication and influencing skills with the ability to translate sophisticated concepts into clear recommendations for senior leadership

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.