Senior RWE Consultant

Barrington James Limited; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Barrington James Limited is seeking a Senior RWE Consultant to support a high-priority pharmaceutical development programme. You will shape real-world data strategy, design studies, and provide scientific leadership across development stages, influencing regulatory and internal decision-making.

The role requires significant expertise in RWE, study design, and collaboration with clinical, regulatory, and biostatistics teams to drive robust evidence generation.

Qualifications

• 8+ years of experience in RWE or related fields within pharma/biotech.
• Strong background in study design and real-world observational research.
• Experience with real-world data sources (claims, EMR, registries).
• Experience in data acquisition, partnerships, and vendor engagement.
• Ability to operate at strategic and hands-on levels across cross-functional teams.
• Excellent communication and stakeholder engagement skills.

Responsibilities

• Lead RWD strategy & acquisition: prioritise sources, evaluate data, and engage providers.
• Develop recommendations on data sources and enable data ingestion.
• Build scalable internal RWD network and ensure data readiness for analyses.
• Define and develop Real-World Evidence strategy and study design for research questions.
• Lead end-to-end protocol development and governance approvals.
• Generate evidence on covariates, trial design optimisation, and subgroup analyses.

Skills

RWE/Epidemiology experience

Study design expertise

Data sources knowledge (claims/EMR/REG

Vendor/data partnerships

Cross-functional collaboration

Regulatory/stakeholder communication

Job description

Contract | Global Pharmaceutical Company

Overview

We are partnering with a large, global pharmaceutical organisation to appoint a Senior RWE Consultant to support a high-priority development programme in a new indication. This is a strategic and execution-focused role, sitting at the intersection of real-world data acquisition, study design, and evidence generation, directly influencing clinical development and decision-making as the programme progresses towards late-stage development.

Key Responsibilities

• Real-World Data (RWD) Strategy & Acquisition
  • Lead the prioritisation and evaluation of RWD sources to support the Indication development programme
  • Develop and present clear recommendations on optimal data sources to cross-functional stakeholders
  • Engage with external data providers to establish collaborations, negotiate access, and enable data ingestion (or external usage where appropriate)
  • Build and advise on a scalable internal RWD network, ensuring data readiness to address key research questions
  • Drive the implementation of the RWD acquisition strategy, ensuring timely access to high-quality data for analysis
• RWE Strategy & Study Design
  • Define and develop the Real-World Evidence strategy to address key research questions, including:
    • Predictors of response and clinical outcomes
    • Dose optimisation
  • Provide expert methodological input on study design within pharmacoepidemiology
  • Design innovative and robust approaches leveraging real-world data
• Scientific Leadership & Delivery
  • Develop concept sheets and full study protocols (minimum of two studies)
  • Lead the end-to-end development of protocols, ensuring scientific rigor and alignment with regulatory and internal expectations
  • Present protocols to internal governance committees and secure approvals
  • Generate evidence to:
    • Identify key covariates impacting efficacy endpoints
    • Inform trial design optimisation
    • Analyse patient subgroups and competitive landscape endpoints

Impact of the Role

• Directly shape clinical development strategy for a novel indication
• Enable data-driven decision making through robust RWE generation
• Establish foundational RWD infrastructure to support ongoing and future research
• Influence how evidence is generated for both regulatory and internal stakeholders

Your Profile

• Significant experience (8+ years) within RWE, Epidemiology, or related fields in the pharmaceutical/biotech industry
• Strong background in study design and methodology, particularly within real-world and observational research
• Proven experience working with real-world data sources (e.g., claims, EMR, registries)
• Experience in data acquisition, partnerships, and vendor/data holder engagement
• Ability to operate at both strategic and hands-on levels (strategy + execution)
• Comfortable working cross-functionally with clinical, regulatory, biostatistics, and medical teams
• Excellent communication and stakeholder engagement skills, including presenting to governance bodies