Biostatistician Manager - Clinical Affairs

April 11

🍂 Massachusetts – Remote

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

💵 $122.7k - $184.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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Diabetes Youth Families

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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 and manage the biostatistics team, providing guidance and mentorship to junior biostatisticians. • Develop and implement statistical methodologies for sample size calculations and power analysis. • Generation of randomization schedules. • Order, collate and interpret large volumes of diverse data and perform exploratory and confirmatory statistical analysis for studies. • Manage various datasets, determine summary statistics, conduct hypotheses testing, estimate statistical models, report formats and other analysis considerations. • Design and conduct complex statistical analyses for clinical studies, RWE, and other data needs. • Prepare statistical analysis plans including development of well-presented mock-up displays for tables, listings, and figures. • Review and provide input to study protocols, and clinical study reports. • Collaborate with cross-functional teams, including Regulatory Affairs, R&D, ADO, and Marketing, to ensure robust statistical support for product validation and claims. • Ensure compliance with regulatory requirements and industry standards for statistical practices. • Present findings and statistical insights to stakeholders, including senior management and regulatory bodies and effectively communicate statistical concepts. • Stay updated with the latest advancements in biostatistics and medical device regulations. • Deliver special projects/ad-hoc reporting as needed. • Develop and maintain internal SOPs to establish formal procedures ensuring the quality of statistical aspects of studies.

🎯 Requirements

• Master's or Ph.D. in Biostatistics, or Statistics. • Minimum of 6+ years of experience in biostatistics within the medical device industry. • Proven experience in navigating complex statistical analyses and sample size calculations. • Strong knowledge of clinical trial design and regulatory requirements. • Strong knowledge of statistical methodologies, experimental design, and analytical and problem-solving abilities. • Effective communication skills, both written and verbal. • Ability to work collaboratively in a fast-paced, multidisciplinary environment. • Proficiency in statistical software, including SAS, R, SPSS, and other relevant tools. • Excellent leadership and team management skills with the ability to multi-task. • Diabetes experience a plus.