Sr. Manager, Medical Affairs - Evidence Generation and Data Insights

Insulet Corporation; Acton (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Insulet Corporation in Acton, MA seeks a Senior Manager, Medical Affairs - Evidence Generation & Data Insights to lead global RWE programs for Omnipod and related products. You will collaborate with Medical Affairs and data science partners to define evidence needs, study designs, and robust analyses across diverse real-world data sources.

You will mentor a team of biostatisticians, provide statistical support to prospective trials, and contribute to scientific publications and presentations for

Qualifications

• 8–10 years of clinical data analysis or real-world data analysis experience.
• Experience in medical strategy, study design, execution, and analysis.
• Post-graduate degree preferred; MPH considered.

Responsibilities

• Lead global RWE strategy for Insulet's product portfolio and development.
• Identify evidence needs and how research using real-world data can support product strategy.
• Generate timely, rigorous evidence to demonstrate benefits of products.
• Define research questions, data sources, study designs, and analyses.
• Draft/provide critical appraisal of protocols and SAPs; collaborate on publications.

Skills

Biostatistics

RWD

Epidemiologic methods

Cross-functional leadership

Study design

Statistical analysis plans

SAS/R/Python

Communication skills

Education

PharmD/MD/PhD

MPH or related degree preferred

Diabetes knowledge (asset)

Tools

SAS

R

Python

Job description

Job Summary

Insulet Corporation is dedicated to improving the lives of people with diabetes. The Senior Manager, Medical Affairs - Evidence Generation & Data Insights will have accountability for global real-world evidence (RWE) generation activities related to Omnipod products. You will work closely with Medical Affairs colleagues and global cross-functional partners to define evidence needs and research questions and develop the strategy to address them. This may also include collaboration with external experts when appropriate. While RWE is the primary focus of this role, you will also serve as a flexible statistical resource across the broader evidence portfolio, providing biostatistical support to prospective clinical trials as needed.

You will be responsible for drafting, reviewing, and providing feedback on study documentation, such as protocols and statistical analysis plans, and collaborating with partners from the data science team to execute analysis using real-world databases. You will be responsible for communicating results to internal cross-functional stakeholders and collaborating on scientific presentation and publication efforts.

You will develop and refine data management procedures, workflows, and best practices in cooperation with other internal stakeholders, including Insulet's Clinical and Data Science Teams.

Responsibilities :

• Contribute to the development and lead the execution of a global RWE strategy supporting Insulet's product portfolio and product development activities
• Serve as a technical expert to cross-functional teams to identify evidence needs and how research studies and RWD can be used to support the product development and commercialization strategy; contribute to the development, maintain, and expand a portfolio of RWD research activities to support these strategies.
• Generate evidence in a timely and strategic manner to demonstrate the benefits of Insulet's portfolio of products
• Define appropriate research questions and data sources, study designs, and analytical approaches that are rigorous and fit-for-purpose.
• Draft and/or provide critical appraisal of study protocol, statistical analysis plan, reports, and manuscripts for research projects
• Identify and contact external stakeholders and key opinion leaders, as needed, for scientific advice and collaboration
• Actively collaborate with cross-functional teams in development, commercial, market access, safety, legal, regulatory, and medical affairs.
• Ensure all research is conducted with a high level of scientific rigor.
• Support cross-functional initiatives to develop and refine internal procedures, workflows, and best practices
• Lead and mentor a team, and develop close connections with data analytics and clinical research teams to ensure strategic alignment on research projects
• Provide biostatistical support to prospective clinical trials as needed, including input on study design, sample size and power calculations, randomization and endpoint definitions, authoring and execution of statistical analysis plans, and statistical interpretation and reporting of results in clinical study reports and regulatory submissions

Education and Experience:

• 8 to 10 years experience working with clinical data analysis or real-world data analysis including the development of medical strategy, study design, execution, and analysis
• Post-graduate degree (PharmD, MD or PhD) in a related field would be preferred, master in public health or related degree with relevant experience will be considered
• A detailed understanding of diabetes and diabetes treatment would be an asset

Skills/Competencies:

• Experience working with a broad range of research projects in academia, at a contract research organization, or in the biopharmaceutical industry
• Knowledge of RWD and application of RWD to observational research
• Demonstrated track record of leading cross-functional teams and executing multiple research projects with minimal supervision
• Exceptional critical thinking to help identify gaps, analyze findings and make recommendations while articulating next steps
• Experience drafting study protocols and statistical analysis plans
• Understanding of the principles of epidemiologic research methods
• Proficiency in clinical trial biostatistics, including hypothesis testing, sample size and power estimation, randomization, handling of missing data, and familiarity with ICH E9 and applicable regulatory expectations for the statistical analysis and reporting of prospective clinical trial data; hands-on experience with statistical programming (e.g., SAS, R, or Python)
• Ability to effectively communicate statistical methodology and analysis of results
• Excellent communication and presentation skills with the ability to present scientific data in a credible and compelling manner. Able to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific