Strategic Real-World Evidence Scientist (Hybrid)

Millipore Corporation; Billerica (MA); Hybrid; USD 131,000 - 211,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Other perquisites

Job summary

EMD Serono seeks a senior leader to oversee Real World Evidence studies, guiding end-to-end non-interventional research and influencing regulatory and strategic plans. You will interface with Global Program Teams and key stakeholders to develop data strategies and strengthen external collaborations.

The role requires advanced epidemiology training, 5+ years in pharma/biotech, and proven experience with real-world data sources, data standards (OMOP/FHIR), and regulatory interactions.

Qualifications

• Doctoral and/or master's degree in Epidemiology, Public Health or related field.
• 5+ years experience in health and life sciences or quantitative data sciences.
• 5+ years of experience in pharmaceutical/biotechnology industry, CRO, or academic setting.
• Experience with secondary data studies across Europe, US, Asia.
• Experience with global regulatory and/or payer submissions and interactions.
• Familiarity with ISPE GPP, GVP, ENCePP.

Responsibilities

• Lead non-interventional studies end to end.
• Provide methodological expertise in strategic forums.
• Interface with Global Program Teams and sub-teams.
• Lead selection of real-world data sources and data strategy.
• Collaborate with regulatory, medical, commercial, and health-economics teams.
• Support interactions with health authorities and respond to regulatory requests.

Skills

Epidemiology knowledge

Regulatory submissions

Biostatistics

Data sources (claims/EMR/registries)

Global collaboration

Education

Doctoral or Master’s in Epidemiology/Public Health

Tools

OMOP CDM

FHIR

CPRD/Optum/IQVIA/TriNetX

Job description

EMD Serono seeks a senior leader to oversee Real World Evidence studies, guiding end-to-end non-interventional research and influencing regulatory and strategic plans. You will interface with Global Program Teams and key stakeholders to develop data strategies and strengthen external collaborations.

The role requires advanced epidemiology training, 5+ years in pharma/biotech, and proven experience with real-world data sources, data standards (OMOP/FHIR), and regulatory interactions.