Senior RWE Scientist & Strategy Lead

EMD Serono, Inc.; Billerica (MA); Hybrid; USD 131,000 - 211,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

EMD Serono, Inc. is seeking an Associate Director, Real World Evidence, to lead end-to-end studies and shape the RWE strategy to support regulatory objectives.

This senior role operates with independence, interfaces with Global Program Teams, and leads data source selection, analysis, and dissemination.

Hybrid role based in Billerica, MA with minimal travel, requiring collaboration across development, regulatory, medical, and payer groups.

Qualifications

• PhD or MSc 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.
• Experience with studies based on secondary data use (claims, EMR, registries).
• Experience with global regulatory submissions and interactions.

Responsibilities

• Serve as the functional product lead and subject matter expert for assigned studies, conducting needs assessments with relevant stakeholders.
• Provide senior-level strategic input into drug development plans and Product Integrated Evidence Plans.
• Execute the RWE strategy for assigned products and lead studies with minimal supervision.
• Represent and defend projects at internal boards, governance committees, and senior management meetings.
• Lead the identification and selection of appropriate real-world data sources, and drive the development of the therapeutic area's real-world data strategy.
• Collaborate closely with development, regulatory, medical, commercial, market access, and PRWE teams.
• Lead Non-Interventional Studies from end to end, including study design, planning, protocol development, monitoring, analysis, study reporting, and dissemination of results.
• Support interactions with health authorities and develop responses to requests from regulatory agencies.
• Foster cross-functional collaboration and maintain and expand external collaborations with other quantitative scientists.

Skills

Health & life sciences

Pharmaceutical industry experience

Regulatory knowledge

Secondary data studies

Education

PhD or MSc in Epidemiology/Public Health

Job description

EMD Serono, Inc. is seeking an Associate Director, Real World Evidence, to lead end-to-end studies and shape the RWE strategy to support regulatory objectives.

This senior role operates with independence, interfaces with Global Program Teams, and leads data source selection, analysis, and dissemination.

Hybrid role based in Billerica, MA with minimal travel, requiring collaboration across development, regulatory, medical, and payer groups.