Insulet Corporation · 1 day ago
Director of Data and Biostatistics (Remote)
United States
Full-time
Remote
Director/Executive
$183K/yr - $275K/yr
8+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes. The Director of Data and Biostatistics will lead data operations for the Clinical Affairs team, overseeing clinical data systems, ensuring data integrity, and supporting regulatory compliance across all clinical studies.
Health CareMedicalMedical Device
Responsibilities
Lead the development and execution of data management strategies for clinical trials involving medical devices
Support the design of clinical studies and ensure accurate interpretation of clinical study data working cross functionally to ensure the needs of the business are met
Lead the development and execution of statistical analysis plans for clinical studies
Oversee the design and validation of clinical databases (e.g., EDC systems) and ensure alignment with study protocols and regulatory requirements
Collaborate with cross-functional teams including Clinical Operations, Medical Affairs, Regulatory Affairs, and Quality Assurance
Ensure high-quality data collection, cleaning, and reporting processes
Manage data management and biostatistics vendors and CROs, ensuring deliverables are met on time and within budget
Develop and maintain SOPs and best practices for biostatistics and data management activities
Provide leadership and mentorship to data management and biostatistics staff. This role will have direct reports
Performs other duties as required
Qualification
Required
Master's degree in Life Sciences, Health Informatics, Biostatistics or related field
Minimum of 8–10 years of data management and/or biostatistics experience in clinical research, with at least 3 years in a leadership role
Strong background in medical device clinical trials and understanding of FDA and ISO regulations (e.g., 21 CFR Part 11, ISO 14155)
Knowledgeable in statistical methods
Proficiency with clinical data systems (e.g., Medidata Rave, Oracle InForm, REDCap)
Experience with device data integration and analysis
Solid understanding of database design, data standards (e.g., CDISC), and data quality assurance
Excellent communication, leadership, and project management skills
Excellent written and effective verbal communication skills
Ability to communicate cross-functionally across the organization
PC skills; word processing, spreadsheet, database, Internet search and utilization
Flexible and able to work in a fast-paced environment
Team player
Ability to organize and judge priorities
Excellent ability to generate and maintain accurate records
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
Company
Insulet Corporation
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform.
1001-5000 employees
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase