Senior Manager, Medical Affairs - Evidence Generation and Data Insights (RWE)

Location: Hybrid, with required on-site work at an hirify.global office in Acton, Massachusetts, United States. Travel to major conferences and team meetings, including internationally, may be required up to 15%.

Annual base salary: $156,100–$234,100 for U.S.-based positions. Incentive compensation may also apply.

Company

hirify.global is a medical device company developing the Omnipod insulin management platform and other wearable drug-delivery technologies for people with diabetes and additional therapeutic needs.

What you will do

• Lead the execution of a global real-world evidence strategy supporting Omnipod products and product development.
• Define evidence needs, research questions, data sources, study designs, and analytical approaches for observational research.
• Draft and critically review study protocols, statistical analysis plans, reports, manuscripts, and regulatory submissions.
• Collaborate with Medical Affairs, Clinical, Data Science, commercial, market access, safety, legal, regulatory, and other cross-functional partners.
• Communicate research findings and support scientific presentations and publications with internal and external stakeholders.
• Lead and mentor a team while developing data management procedures, workflows, and research best practices.

Requirements

• 8–10 years of experience in clinical data analysis or real-world data analysis, including medical strategy, study design, execution, and analysis.
• Experience with real-world data and observational research, epidemiologic methods, and a broad range of research projects.
• Proficiency in clinical trial biostatistics, including hypothesis testing, sample size and power estimation, randomization, missing data, and endpoint definitions.
• Hands-on statistical programming experience with SAS, R, or Python, plus knowledge of ICH E9 and applicable regulatory expectations.
• Experience drafting study protocols and statistical analysis plans, interpreting results, and communicating scientific findings.
• Post-graduate degree in a related field is preferred; relevant experience with a master’s degree in public health or a related discipline will be considered.

Nice to have

• Detailed understanding of diabetes and diabetes treatment.
• Experience in academia, a contract research organization, or the biopharmaceutical industry.
• Experience collaborating with external experts and key opinion leaders.

Culture & Benefits

• Collaborative, proactive, and flexible working environment with a hands-on approach.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Paid time off and employee wellness programs.
• Opportunities to collaborate across global medical, clinical, data science, and commercial teams.