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Sr Manager Biostatistics at Dexcom

, California, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Jan, 26

Salary

0.0

Posted On

23 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biostatistics, Study Design, Protocol Development, Statistical Analysis, Regulatory Submissions, Data Analysis, Team Management, Statistical Consultation, Cross-Functional Collaboration, Statistical Methods, Programming, Advanced Techniques, Industry Standards, Data Management, Clinical Research, Medical Affairs

Industry

Medical Equipment Manufacturing

Description

Provide strategic guidance on study design, protocol development, CRF review, endpoint selection, statistical analysis methods, and definition of acceptance criteria. 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. Ensure adherence to internal standards, regulatory requirements, and industry best practices. Provide statistical consultation across departments and perform other duties as assigned. Experience managing biostatistics teams and operations. Proficient in statistical methods and programming; expertise in advanced techniques preferred. 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.

Responsibilities

Provide strategic guidance on study design and statistical analysis methods. Collaborate with cross-functional teams and ensure adherence to regulatory requirements.