We anticipate the application window for this opening will close on - 31 Oct 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

SENIOR STATISTICIAN

For over a decade, Medtronic has been at the forefront of transforming stroke care, leading the fight against both acute ischemic stroke (AIS) and hemorrhagic stroke. By equipping physicians with innovative technologies, we empower their expertise to improve patient outcomes and redefine neurovascular care. Our commitment extends beyond medical device development—we actively collaborate with the medical community to drive meaningful advancements in stroke treatment. Together, we are changing the way stroke is managed worldwide, making a lasting difference for the millions of patients affected every day.

Join a diverse team of innovators who bring their worldview, unique backgrounds, and individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Responsibilities

• Design and Execution: Design, plan, and execute biostatistical components of research and development projects essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products.
• Methodology Application: Use sound statistical methodology to conduct studies throughout the product lifecycle.
• Oversight of Deliverables: Oversee statistical support and deliverables to ensure adherence to study-specific requirements and consistent application of relevant methods across the portfolio.
• Protocol Preparation: In development-phase projects, prepare the statistical component of protocols that meet project objectives, health authority guidelines, and clinical trial methodology standards.
• Novel Methodologies: Research, develop, and apply novel statistical theories, methods, and software.
• Data Interpretation: Summarize and interpret data into tabular and graphical formats amenable to statistical inference, responsible for the statistical component of reports describing studies, outcomes, and methods used.
• Collaboration: Provide specifications and directions to clinicians/statistical programmers.
• Regulatory Support: Support the regulatory review and approval of experimental therapies.
• Trial Design Partnership: Partner in trial design and establish standards for clinical conduct, data collection, management, and reporting.

Other Responsibilities

• Study Design Expertise: Apply statistical knowledge to the design of clinical studies, ensuring that study objectives can be met, including the calculation of sample size and power.
• Case Report Form Development: Assist in the development and review of case report forms to ensure efficient and accurate data collection.
• Credibility Management: Identify potential threats to study credibility, validity, and data integrity, working with the study team to prevent, track, and manage problems.
• Statistical Analysis Plan: Write the statistical analysis plan for the study, if required.
• Regulatory Agency Interaction: Take a leadership role in responding to questions from FDA, FDA Advisory Panels, and other regulatory agencies, and in negotiations regarding study design and interpretation.
• Data Analysis Tools: Use a variety of statistical methods and software tools to analyze and display data from clinical studies, ensuring methods are appropriate for the data collected.
• Documentation Validation: Validate and provide clear documentation of analysis programs.
• Report Writing: Write Results and Methods sections of reports and manuscripts as needed, ensuring accurate interpretation of statistical and clinical findings in regulatory submissions.
• Consultation: Consult with non-clinical staff on statistical and analysis issues.
• Process Improvement: Lead the development of policies and procedures for process improvements and standardization for the department and statistics group.
• Team Contribution: Attend and contribute