Associate Director I/II, Real World Data Statistics

AstraZeneca
Bengaluru
Workplace: OnsiteFull timeFunction: Executive & General ManagementExperience: 7+ yearsEducation: phdSkills: ["Communication","Influencing","Mentoring","Knowledge-sharing","Code review"]

Lead regulatory-grade real-world evidence work using disease registry and longitudinal observational data to support rare disease programs. Oversee statistical strategy and advanced analyses such as survival, causal inference, propensity score methods, and longitudinal modeling, ensuring reproducibility, audit readiness, and compliance with FDA RWE and EMA registry guidance. Collaborate with clinical, epidemiology, regulatory, and registry operations teams, mentor RWD statisticians, and translate findings into executive narratives and regulatory submissions.

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FursaFursa
AstraZeneca
AstraZeneca
1 month ago

Associate Director I/II, Real World Data Statistics

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Source: Company careers pageValidated by: Fursa AI
Last checked: 27 days agoStatus: Live

Job Summary

Lead regulatory-grade real-world evidence work using disease registry and longitudinal observational data to support rare disease programs. Oversee statistical strategy and advanced analyses such as survival, causal inference, propensity score methods, and longitudinal modeling, ensuring reproducibility, audit readiness, and compliance with FDA RWE and EMA registry guidance. Collaborate with clinical, epidemiology, regulatory, and registry operations teams, mentor RWD statisticians, and translate findings into executive narratives and regulatory submissions.
Location: Bengaluru
Workplace: Onsite
Employment Type: Full time
Job Function: Executive & General Management
Seniority: Mid level

Key Responsibilities

  • •Oversee the statistical vision and analytical strategies for registry-based evidence used in regulatory submissions and decisions across rare disease programs.
  • •Lead design, implementation, and validation of survival, causal inference, propensity score, and longitudinal models for registry data meeting regulatory expectations.
  • •Define and implement robust registry-specific statistical approaches to address missingness, data linkage, confounding, and outcome validation.
  • •Oversee development of regulatory-quality deliverables including SAPs, statistical outputs, and regulatory briefing documents aligned to FDA RWE and EMA guidance.
  • •Mentor and support Real World Data Statisticians, building capability through knowledge-sharing, code review, and guidance.

Key Requirements

  • •PhD (minimum 7 years) or Master’s (minimum 10 years) in relevant industry experience.
  • •Advanced degree or equivalent experience in statistics, biostatistics, or epidemiology.
  • •Expert proficiency with R and/or SAS; solid understanding of SQL or Python for data engineering and validation.
  • •Proven track record generating real-world evidence for rare disease programs or patient populations.
  • •Demonstrated ability leading regulatory submissions using registry-based analyses and presenting to health authorities or advisory settings.
Experience:7+ yearsRare diseaseReal-world evidenceRegistriesEpidemiologyPharmacoepidemiology
Education:PhD / Doctorate
Skills:CommunicationInfluencingMentoringKnowledge-sharingCode review
Tech Stack:RSASSQLPython

Company Brief

AstraZeneca
Global biopharmaceutical company discovering, developing and commercializing prescription medicines across oncology, cardiovascular, renal & metabolism, respiratory, and immunology, focused on innovative therapies and vaccines to improve patient outcomes worldwide.
Industry: Pharmaceuticals
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Cambridge, United Kingdom
Founded: 1999
Glassdoor
Glassdoor: 3.8
WebsiteLinkedIn