Head of Real-World Evidence

Alzheon, Inc.; Framingham, Northern (MA, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Alzheon, Inc. seeks a Head of Real-World Evidence to build and lead the RWE function. This role defines the evidence strategy, translating external data sources into regulatory and payer‑relevant insights for Alzheimer’s disease programs.

The position sits at the intersection of epidemiology, biostatistics, and market access, combining hands‑on analysis with leadership, protocol reviews, and external collaboration with CROs and data partners.

Qualifications

• 10+ years of real‑world evidence or similar experience.
• End‑to‑end observational studies ownership from question to publication.
• Familiarity with causal inference methods for observational data.
• Experience presenting evidence to regulators or payers.
• Peer‑reviewed publications in relevant fields.

Responsibilities

• Define and own the real‑world evidence strategy across the portfolio.
• Design observational research including natural history and external controls.
• Evaluate and govern external data assets (claims, EHRs, registries).
• Develop protocols and analysis plans aligned with regulatory expectations.
• Collaborate on economic models and payer evidence dossiers.
• Lead publication planning and present findings at venues.

Skills

Epidemiology

Biostatistics

Observational Studies

Data Analysis

Causal Inference

Regulatory Communication

Publication Planning

Education

Master’s in Epidemiology / Biostatistics / Public Health

PhD preferred

Tools

R

SAS

OMOP data model

Job description

• Location On-Site or Hybrid (Framingham, MA)

Company Overview

Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease and other neurodegenerative disorders. We are committed to developing innovative medicines by directly addressing the underlying pathology of devastating neurodegenerative disorders. Our lead Alzheimer’s clinical candidate, ALZ-801 , is an oral agent in Phase 3 development as a potentially disease modifying treatment for AD. ALZ-801 is an oral small molecule that fully blocks formation of neurotoxic soluble amyloid oligomers in the brain. Our clinical expertise and technology platform are focused on developing drug candidates and diagnostic assays using a precision medicine approach based on individual genetic and biomarker information to advance therapies with the greatest impact for patients.

Our experienced and passionate drug development team is focused on applying precision medicine, cutting-edge disease biomarkers, brain imaging and unique biologic insights to advance therapies with the greatest impact for patients. We are seeking individuals with an entrepreneurial spirit to join our team and help make the first oral Alzheimer’s disease-modifying therapy a reality for patients and their families, in a few short years.

Position Overview

Alzheon is seeking a Head of Real-World Evidence to build and lead the company’s RWE function. This individual will define the evidence strategy that complements our clinical development program, translating external data sources such as administrative claims, electronic health records, registries, and natural history cohorts into evidence that supports regulatory interactions, payer decisions, and clinical practice in Alzheimer’s disease.

The role sits at the intersection of epidemiology, biostatistics, and market access, and carries responsibility for study design, execution through external partners, publication, and the scientific credibility of everything the function produces. It is a hands‑on leadership position. The successful candidate will set strategy, but will also read the protocols, review the analytic specifications, and defend the methods in front of regulators, payers, and peer reviewers.

Key Responsibilities

• Define and own the real‑world evidence strategy across the portfolio, aligned with clinical development, regulatory, medical affairs, and market access priorities
• Design and oversee observational research, including natural history studies, external control arms, disease burden and treatment pattern analyses, and comparative effectiveness studies
• Evaluate, license, and govern external data assets, including claims databases, electronic health records, disease registries, and linked biomarker or neuroimaging datasets, and assess their fitness for purpose before committing to a study
• Develop protocols, statistical analysis plans, and study reports that meet regulatory expectations for real‑world data, including FDA and EMA guidance on RWE and target trial emulation principles
• Partner with health economics and market access colleagues on economic models, budget impact analyses, and payer evidence dossiers
• Lead publication planning for RWE deliverables and present findings at scientific congresses and in peer‑reviewed journals
• Select and manage external vendors, academic collaborators, and CROs, holding them to timeline, budget, and methodological standards
• Grow the function over time, including hiring and mentoring epidemiologists, data scientists, and analysts as the portfolio expands

Requirements

• Master’s degree minimum in Epidemiology, Biostatistics, Public Health, Health Services Research, or a related quantitative discipline; MPH, DrPH, or PhD strongly preferred
• 10+ years of experience in real‑world evidence, pharmacoepidemiology, or outcomes research within biopharma, a CRO, an academic research center, or a payer organization
• Demonstrated ownership of observational studies end to end, from question formulation and protocol through analysis, interpretation, and publication
• Working command of causal inference methods for observational data, including propensity score approaches, marginal structural models, and sensitivity analyses for unmeasured confounding
• Hands‑on familiarity with large healthcare databases, for example ADNI or other observational studies or EHR‑derived datasets, together with a realistic view of their limitations
• Experience presenting evidence to regulators, payers, or advisory boards, and translating technical findings for non‑technical audiences
• Track record of peer‑reviewed publication as a primary or senior author

Preferred Qualifications

• PhD in Epidemiology or a closely related field
• Experience in Alzheimer’s disease, neurodegeneration, or another CNS therapeutic area, including familiarity with cognitive and functional outcome measures
• Experience supporting a regulatory submission or an HTA or payer dossier with real‑world data
• Fluency in R or SAS sufficient to review and interrogate analytic work produced by others
• Familiarity with common data models such as OMOP and with modern data governance and privacy requirements

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.