Senior Manager, Biostatistics

Job not on LinkedIn

October 31

Apply Now

Receive Emails with Similar Jobs

Dexcom

WebsiteLinkedInAll Job Openings

Healthcare Insurance • Biotechnology • Wearable Technology

Dexcom is a leading provider of continuous glucose monitoring (CGM) systems, revolutionizing how people manage diabetes and track their glucose levels. Known for their best-in-class glucose biosensing technology, Dexcom offers products like the Dexcom G7 CGM system, which provides real-time glucose monitoring and insights to help individuals become healthier. Founded in 1999, Dexcom has consistently innovated in the field of diabetes management, empowering users to take control of their health with accurate and advanced glucose monitoring solutions. Their products are designed for both adults and children and do not require a prescription.

10,000+ employees

Founded 1999

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• Lead a team of biostatisticians, managing performance, resource planning, prioritization and timelines • Direct statistical design, analysis, and reporting for feasibility, pivotal, post-market, and RWE clinical studies • Provide strategic guidance on study design, protocol development, CRF review, endpoint selection, statistical analysis methods, and definition of acceptance criteria • Lead or oversee the development and execution of Statistical Analysis Plans (SAPs), ensuring data integrity and analytical rigor • Guide statistical contributions to regulatory submissions (e.g., IDEs, PMAs, 510(k)s) and represent Biostatistics in interactions with regulatory agencies • Support scientific publications through data analysis and interpretation for abstracts, posters, and manuscripts • Collaborate with cross-functional teams including Data Management, Clinical, R&D, Regulatory Affairs, and Medical Affairs • Identify and implement innovative statistical methodologies to address complex study challenges • Communicate project status, risks, and scope changes to leadership

🎯 Requirements

• M.S. in Biostatistics, Statistics, Data Science, or related field with 10+ years of experience; Ph.D. preferred • Minimum 2 years of team management or supervisory experience • Industry experience in pharmaceutical, medical devices, or biotechnology highly desirable • Experience managing biostatistics teams and operations • Proficient in statistical methods and programming; expertise in advanced techniques preferred • Strong SAS programming skills; R experience is a plus.

🏖️ Benefits

• A full and comprehensive benefits program • Growth opportunities on a global scale • Access to career development through in-house learning programs and/or qualified tuition reimbursement • An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.