Associate Director I/II, Real World Data Statistics

Job description

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 Master’s 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 medicines. 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