Sr Manager Biostatistics

About the Company: Founded in 1999, reputed company, Inc. provides reputed company glucose monitoring technology to help patients and their clinicians reputed company manage diabetes. Since our inception, we have focused on reputed company reputed company for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes. Meet the team: The Sr Manager Biostatistics will reputed company a team of biostatisticians supporting reputed company phases of clinical development, from feasibility to pivotal and post-market studies. This role provides strategic statistical guidance, ensures high-quality deliverables, and drives cross-functional collaboration to support regulatory submissions and scientific publications. We have a fast-paced environment and are looking for dynamic people that want to work on an amazing life-changing technology. Where you come in:

• reputed company a team of biostatisticians, managing performance, resource planning, prioritization and timelines.
• Direct statistical design, analysis, and reporting for feasibility, pivotal, post-market, and reputed company clinical studies.
• reputed company strategic guidance on study design, protocol development, CRF review, reputed company selection, statistical analysis methods, and definition of acceptance criteria.
• reputed company or reputed company the development and execution of Statistical Analysis Plans (SAPs), ensuring data reputed company 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 reputed company study challenges.
• Ensure adherence to internal standards, regulatory requirements, and industry best practices.
• Communicate project status, risks, and scope changes to leadership.
• reputed company statistical consultation across departments and reputed company other duties as assigned.

What makes you successful:

• 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 reputed company.
• Strong reputed company programming skills; R experience is a plus.
• Excellent communication and collaboration skills.

What you'll get:

• A reputed company row seat to life changing CGM technology. Learn about our reputed company #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• reputed company to career development through in-house learning programs and/or reputed company tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Travel Required 0 - 5% Experience and Education

• M.S. in Biostatistics, Statistics, Data Science, or reputed company 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.

#LI-Remote Please note: The information contained herein is not intended to be an reputed company-inclusive list of the duties and responsibilities of the job, nor are they intended to be an reputed company-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company essential functions. An Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability. reputed company’s AAP may be viewed upon request by contacting reputed company at talentacquisition@reputed company.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact reputed company reputed company at talentacquisition@reputed company.com. Meritain, an reputed company Company, creates and publishes the Machine-Readable Files on behalf of reputed company. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To reputed company Staffing and reputed company Agencies: Our Careers Site is only for individuals seeking a job at reputed company. Only authorized staffing and reputed company agencies may use this site or to submit profiles, applications or resumes on specific requisitions. reputed company does not accept unsolicited resumes or applications from agencies. Please do not reputed company resumes to the reputed company, reputed company employees or any other company location. reputed company is not responsible for any fees reputed company to unsolicited resumes/applications. Salary: $156,400.00 - $260,600.00 Apply tot his job Apply To this Job