Director of Data and Biostatistics

Job not on LinkedIn

November 26

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $183.2k - $274.8k / year

⏰ Full Time

🔴 Lead

👔 Director

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Diabetes Youth Families

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Healthcare Insurance • Hardware

Diabetes Youth Families is a company that provides wearable insulin delivery solutions for diabetes management. Their primary products, such as the Omnipod 5 and Omnipod DASH systems, offer tubeless and automated insulin delivery for people with Type 1 and Type 2 diabetes, allowing users to manage their condition without the need for multiple daily injections. The systems integrate with continuous glucose monitoring (CGM) devices and can be controlled via compatible smartphones, enhancing the freedom and lifestyle of individuals living with diabetes. With a focus on reducing the burden of diabetes management, they offer financial assistance, support resources, and trial programs to help users adapt to their innovative solutions. The company emphasizes making life simpler while managing diabetes through technology-driven insulin management systems.

11 - 50 employees

Founded 1938

⚕️ Healthcare Insurance

🔧 Hardware

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs