Job Title: Director, Real World Statistics
Location: Bengaluru, Karnataka, India
Job ID: R-235769
Date Posted: 02 Nov 2025
🔹 Introduction to the Role
Join the Epidemiology and Real World Science team within the Alexion–AstraZeneca Rare Disease Unit, where Real World Data (RWD) is leveraged to transform patient access to life-changing rare disease therapies.
As the Director of Real World Statistics, you will provide statistical expertise for rare disease programs, with a strong focus on disease registries, observational cohorts, and regulatory submissions. You will play a key leadership role in method development, mentoring, regulatory interactions, and delivery of high-quality statistical analyses aligned with global submission requirements.
🔹 Key Accountabilities
1. Statistical Analysis & Method Development
Design and implement advanced statistical analyses using registry data, natural history studies, EMR, and claims datasets.
Develop and validate methodologies for Real World Evidence (RWE) derived from registry sources.
Prepare regulatory-quality outputs including statistical reports and Clinical Study Reports (CSRs).
2. Regulatory Strategy & Support
Collaborate closely with registry teams and support Alexion in regulatory interactions.
Ensure registry-derived analyses align with regulatory expectations and submission strategies.
Contribute statistical expertise to regulatory submissions using real-world data.
3. Leadership & Mentorship
Mentor junior statisticians and data scientists in regulatory-compliant registry analysis.
Lead multidisciplinary teams and foster best practices in statistical analysis and regulatory documentation.
4. Cross-Functional Collaboration
Partner with internal teams involved in registry programs, medical affairs, regulatory affairs, and real-world evidence generation.
🔹 Essential Skills & Experience
Qualifications
Option 1 (Doctoral Track):
Doctoral degree in Biostatistics, Statistics, Epidemiology, Mathematics, Data Science, or related field.
Minimum 6+ years of industry experience (pharma, biotech, consulting).
Option 2 (Master’s Track):
Master’s degree in Computer Science, Statistics, Mathematics, Data Science, or related field.
Minimum 10+ years of industry experience.
Work Environment
Typical office-based position requiring the ability to:
Work on computers and communication tools (phone, email, video).
Engage in analytical and problem-solving tasks.
Collaborate with colleagues and maintain availability during standard business hours.
🔹 Desirable Skills & Experience
Strong hands-on programming expertise in R, SAS, SQL with regulatory-compliant programming standards.
Proven success in regulatory submissions involving registry data.
Substantial experience with disease registries and natural history studies.
In-depth knowledge of regulatory standards including ICH guidelines, FDA RWE Framework, and EMA guidance on registry-based studies.
Experience leading regulatory-focused statistical projects.
Ability to build long-term collaborative relationships with regulatory agencies.
🔹 Working Model
Hybrid working structure: minimum 3 days per week in the office.
Flexible approach balancing collaboration with individual needs.
🔹 Culture at AstraZeneca & Alexion
Inclusive, diverse, patient-driven work culture focused on meaningful impact.
Encourages bold thinking, kindness, and collaboration.
Offers leadership support, tailored development programs, and a community-driven environment.
A place where your career becomes a journey of purpose and innovation.
🔹 Application Timeline
Date Posted: 03 Nov 2025
Closing Date: 29 Nov 2025
🔹 Equal Employment Opportunity Statement
Alexion is an Equal Employment Opportunity and Affirmative Action employer committed to fostering a culture of belonging. Employment decisions are made without regard to characteristics such as race, religion, gender, age, disability, veteran status, genetic information, or any other status protected by law.
Reasonable accommodations are available for candidates and employees upon request.
Alexion participates in E-Verify.
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