Senior Manager – Real-World Evidence (RWE) & Epidemiology
Experience: Minimum 5 Years | Location: Mumbai, India – Mumbai Development Center (EPD) | Category: Research & Development | Employment Type: Full-Time
Company Overview:
Join a leading pharmaceutical organization driving innovation in clinical research and real-world evidence generation. The Senior Manager – RWE & Epidemiology will provide epidemiological and methodological expertise to transform real-world data (RWD) into actionable insights, supporting Clinical Development, Medical Affairs, and strategic decision-making across the Established Pharmaceuticals Division (EPD).
Role Overview:
This role coordinates, delivers, and oversees the methodological design, analysis, and reporting of observational clinical studies while ensuring compliance with international and local regulatory guidelines and EPD policies. The Senior Manager serves as the primary expert in RWE methodology, guiding CROs, reviewing study protocols, and providing statistical and epidemiological input for clinical studies and medical dossiers.
Key Responsibilities:
Lead the design, analysis, and reporting of observational clinical studies including registries, case-control studies, cross-sectional studies, and secondary database studies.
Determine appropriate statistical methodologies, endpoint definitions, and sample sizes to ensure high-quality RWE generation from RWD.
Brief and oversee CROs on statistical analyses, reviewing statistical analysis plans, study reports, and database locks.
Collaborate with medical leads to interpret study results accurately and support dossier submissions.
Present RWE and epidemiological findings at external meetings, including KOL meetings, investigator meetings, and regulatory interactions.
Serve as the primary reviewer for epidemiological and methodological literature relevant to the company’s compounds.
Stay current with evolving epidemiological and methodological standards, disseminating relevant literature, guidelines, and updates to cross-functional teams.
Provide methodological input to HEOR studies, pharmacoeconomic models, global value dossiers, and behavioral design studies including adherence projects.
Drive strategic RWE initiatives to maximize insights from real-world data, enhancing clinical knowledge and supporting evidence-based decision-making.
Supervisory Responsibilities:
Individual contributor; no direct or indirect reports.
Position Accountability:
Accountable for the design, analysis, and reporting of observational studies.
Accountable for methodological review of affiliate study protocols.
Accountable for providing epidemiological support to RWE strategies and initiatives.
Educational Qualification:
PhD or MSc in Biostatistics, Mathematics, Epidemiology, or Health Economics.
Candidates with a Statistics degree must have additional training in Epidemiology and RWE.
Candidates with an Epidemiology degree must have additional training in Statistics.
Experience Requirements:
Minimum 5 years of relevant experience in the pharmaceutical or life sciences environment.
Demonstrable expertise in designing and conducting observational studies (registries, case-control, secondary database studies, pragmatic trials).
Experience converting RWD into RWE using advanced statistical techniques (e.g., Target Trial Emulation, G-computation, E-values, Targeted Maximum Likelihood Estimation).
Proficiency in statistical analysis software such as SAS and/or R.
Ability to explain complex epidemiological concepts to non-technical stakeholders.
Knowledge of HEOR, behavioral science, or adherence models is advantageous.
Key Skills and Competencies:
Strong methodological and epidemiological expertise.
Analytical thinking with advanced statistical capabilities.
Excellent communication and presentation skills for cross-functional teams and external stakeholders.
Ability to work independently, manage multiple studies, and provide strategic guidance.
Why Join Us:
Work at the forefront of RWE generation, contributing to evidence-based clinical decisions.
Collaborate with cross-functional teams, KOLs, and regulatory stakeholders.
Opportunity to influence strategic initiatives and advance scientific knowledge across multiple therapeutic areas.
Participate in a global, innovation-driven environment that values expertise, collaboration, and professional growth.
Apply Now: Advance your career as a Senior Manager – RWE & Epidemiology in Mumbai and play a pivotal role in transforming real-world data into actionable clinical evidence.
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