Director of Data and Biostatistics (Remote)

Job Title: Director of Data and Biostatistics

Department: QA Clinical

Manager/Supervisor: Senior Director, Clinical Affairs

FLSA Status: Exempt

Position Overview

The Director of Data and Biostatistics will lead data operations for our Clinical Affairs team focused on medical devices. This role will be responsible for overseeing the design, implementation, and maintenance of clinical data systems, ensuring data integrity, and supporting regulatory compliance across all clinical studies. In addition, this role will be responsible for overseeing the statistical analysis of clinical study data ensuring appropriate statistical methods and accurate analyses to evaluate efficacy and safety and answer research related questions.

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.
  
  

Education And Experience

• 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.
  
  

Skills/Competencies

• 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.
  
  

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired).

Additional Information

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $183,225.00 - $274,837.50 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including:

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.
  
  

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. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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