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Senior Manager Rwe & Epidemiology

5 years
Not Disclosed
10 Dec. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Manager – Real-World Evidence (RWE) & Epidemiology

Location: Mumbai, India – Mumbai Development Center (EPD)
Category: Research & Development

Role Overview

The Senior Manager, RWE & Epidemiology, plays a critical role in advancing Real-World Evidence generation within Abbott’s Established Pharmaceuticals Division (EPD). This position provides methodological and epidemiological expertise to support Clinical Development and Medical Affairs, ensuring high-quality RWE output aligned with international regulatory standards and internal EPD policies.

The role also oversees the operational and methodological aspects of outsourced RWE research activities, working closely with CRO partners and cross-functional stakeholders.


Key Responsibilities

RWE and Epidemiology Leadership

  • Lead and manage multiple Real-World Evidence projects across diverse therapeutic areas, occasionally including interventional studies.

  • Serve as the primary methodological expert for designing, analyzing, and reporting observational clinical studies, including epidemiological surveys, registry studies, nested case-control studies, cross-sectional studies, and secondary database research.

  • Define statistical methodologies, endpoint strategies, and sample-size determinations to ensure rigor and minimize bias in RWE generation.

Protocol Development and Statistical Oversight

  • Write and review statistical components of clinical study protocols to ensure appropriate methodology and compliance with scientific standards.

  • Provide detailed methodological and statistical input to CRO partners, including reviewing statistical analysis plans, study outputs, and data tables.

  • Approve statistical analysis plans and database lock for designated EPD studies.

Scientific Interpretation and Cross-Functional Support

  • Collaborate with medical leads to interpret clinical outcomes and ensure accurate communication of study results.

  • Support regulatory dossier submissions and respond to methodological and statistical queries related to the development program.

  • Represent RWE and Epidemiology at investigator meetings, KOL engagements, regulatory discussions, and scientific forums.

Strategic RWE Development

  • Drive EPD’s RWE strategy by transforming Real-World Data (RWD) into actionable Real-World Evidence using data-driven methodologies.

  • Serve as the subject-matter expert for reviewing epidemiological evidence and external research related to EPD compounds.

Continuous Learning and Knowledge Sharing

  • Stay current with emerging epidemiological, statistical, and methodological advancements; review literature; and attend conferences and training programs.

  • Disseminate updated insights, regulatory guidelines, and scientific literature to Biometrics, Clinical Development, and Medical Affairs teams.

Additional Contributions

  • Contribute to HEOR review activities, pharmacoeconomic modeling, and Global Value Dossier development.

  • Support Behavioral Science and Adherence Studies, including studies incorporating digital health or telehealth solutions.


Supervisory Responsibilities

  • Direct Reports: None

  • Indirect Reports: None


Scope and Accountability

  • Accountable for the scientific design, methodology, analysis, and reporting of observational clinical studies.

  • Responsible for methodological review of affiliate-level protocols.

  • Provide comprehensive epidemiological and methodological support for RWE strategy execution.


Qualifications

  • PhD or MSc in Biostatistics, Statistics, Mathematics, Epidemiology, or Health Economics.

  • If degree is in Statistics: additional training in Epidemiology and RWE methodologies.

  • If degree is in Epidemiology: additional training in advanced statistical techniques.


Experience Required

  • Minimum 5 years of experience in the pharmaceutical industry, specializing in observational research or RWE generation.

  • Proven expertise in designing and conducting observational studies (registries, case-control, database analyses, pragmatic trials).

  • Experience in transforming RWD into RWE using advanced statistical methods (Target Trial Emulation, G-computation, E-values, TMLE).

  • Hands-on experience in statistical programming using SAS and/or R.

  • Ability to clearly explain epidemiological and statistical concepts to non-technical stakeholders.

  • Knowledge of HEOR and behavioral science/adherence models is an added advantage.