Associate Director RWE Science

Waltham, MA - USA

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Associate Director Real World Evidence (RWE) Science Phase IV / Post-Approval (Contract)

Location: United States (Remote; Eastern Time business hours preferred)
Duration: 7-Month Contract (Full-Time 40 hours/week)
Start: Targeting Early March 2026

We are seeking an experienced Associate Director Real World Evidence (RWE) Science to provide coverage for a Phase IV / post-approval RWE portfolio within a global Medical Affairs environment. This is a senior-level individual contributor role requiring deep epidemiology and real-world evidence expertise strong methodological leadership and the ability to independently manage ongoing studies with minimal ramp-up.

This position supports global stakeholders including Europe and requires flexibility for early morning meetings aligned to EU collaboration.

Key Responsibilities

Lead scientific oversight of Phase IV and post-approval real-world evidence (RWE) and observational studies
Provide methodological and technical leadership for study design feasibility assessments and evidence planning (EU focus)
Oversee vendors/CROs conducting outsourced analyses; review protocols statistical analysis plans and outputs to ensure scientific rigor
Conduct and/or supervise systematic literature reviews (SLRs) and meta-analyses
Contribute to development of RWE plans aligned with regulatory HTA and post-approval commitments
Support retrospective analyses leveraging real-world data sources (claims EHR registries)
Guide protocol development for observational studies and pragmatic trials
Perform evidence reviews to inform regulatory submissions reimbursement strategy and medical strategy
Collaborate with Regional Medical Affairs on scientific exchange and external RWE engagement
Support development of abstracts posters manuscripts and internal scientific communications

Required Qualifications

Advanced degree (MD PhD or MS) in Epidemiology Biostatistics Public Health or related field
8 10 years of progressive experience in epidemiology and real-world evidence
Minimum 5 years of Pharma or Biotech industry experience
Strong expertise in:
- Phase IV / post-approval epidemiologic study design
- Retrospective real-world data (RWD) analyses
- Observational research methodologies
Experience overseeing vendors/CROs and critically evaluating statistical methodologies
Proficiency with statistical software (R SAS Stata) and strong understanding of claims/EHR data structures
Demonstrated ability to work autonomously in a global matrixed environment
Flexibility to support EU collaboration across time zones

Preferred Qualifications

Experience supporting regulatory or HTA-facing RWE deliverables
Vaccines infectious disease or public health epidemiology background
Experience with systematic literature reviews and meta-analyses
R programming skills including simulations power calculations or Shiny applications
Experience with data extraction cleaning and standardization for RWD
Prior authorship of scientific publications and presentations
Experience supporting EU feasibility assessments and RWE expectations

Role Highlights

Senior-level RWE leadership without people management responsibilities
High-visibility Phase IV and real-world effectiveness portfolio
Global collaboration with strong EU engagement
Remote flexibility within the United States

Qualified candidates with deep RWE and epidemiology expertise strong methodological grounding and Phase IV experience in Pharma/Biotech are encouraged to apply.

Job Title: Associate Director Real World Evidence (RWE) Science Phase IV / Post-Approval (Contract) Location: United States (Remote; Eastern Time business hours preferred) Duration: 7-Month Contract (Full-Time 40 hours/week) Start: Targeting Early March 2026 We are seeking an experienced Associa...