Dexcom Deutschland GmbH · 1 week ago
Sr Manager Biostatistics
United States
Full-time
Remote
Senior Level, Lead/Staff
$156K/yr - $261K/yr
10+ years expDexcom Corporation is a pioneer in continuous glucose monitoring technology aimed at improving health outcomes for diabetes management. The Sr Manager Biostatistics will lead a team of biostatisticians, providing strategic guidance and ensuring high-quality deliverables for clinical studies and regulatory submissions.
Medical Device
Responsibilities
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
Ensure adherence to internal standards, regulatory requirements, and industry best practices
Communicate project status, risks, and scope changes to leadership
Provide statistical consultation across departments and perform other duties as assigned
Qualification
Required
Experience managing biostatistics teams and operations
Strategic thinker with strong decision-making skills
Proficient in statistical methods and programming; expertise in advanced techniques preferred
Capable of independent work and team leadership with minimal oversight
Strong SAS programming skills; R experience is a plus
Excellent communication and collaboration skills
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
Preferred
Expertise in advanced statistical techniques
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.
Company
Dexcom Deutschland GmbH
Die 1999 gegründete Dexcom, Inc.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase