We anticipate the application window for this opening will close on - 15 Aug 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

 
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, their unique backgrounds and their 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 may include the following and other duties may be assigned. 

• Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. 
• Uses sound statistical methodology to conduct studies relating to the life cycle of the product. 
• Oversight of statistical support and deliverables for ensuring adherence to study specific requirements as well as consistent applications of relevant methods across the portfolio. 
• In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. 
• Research, develop and/or applies novel statistical theories, methods, and software. 
• Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used. 
• Provides specifications and directions to the clinicians/statistical programmers. 
• Supports the regulatory review and approval of the experimental therapies. 
• Partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.  

Other responsibilities: 

• Applies statistical knowledge and experience to the design of clinical studies, ensuring that study objectives can be met.  This requires calculation of sample size and power, as well as possible determination of appropriate design assumptions from published literature. 
• Assists in development and review of case report forms, ensuring data will be collected efficiently and accurately. 
• Identifies potential threats to study credibility, validity, and data integrity and works with study team to prevent, track, and manage potential problems. 
• Writes the statistical analysis plan for the study, if required.  
• Takes a leadership role in responding to relevant questions from FDA, FDA Advisory Panels, and/or other regulatory agencies, and in negotiations with regulatory agencies regarding study design and interpretation.  
• Uses a variety of statistical methods and software tools to analyze and display data from clinical and other studies, including more advanced methods.  Methods must be appropriate for the kind of data collected and required assumptions must be tested. 
• Validates and provides clear documentation of analysis programs. 
• Writes Results and Methods sections of reports and manuscripts as needed and ensures interpretation of statistical and clinical findings in regulatory submissions, reports, and manuscripts accurately reflect the data collected. 
• Consults with other (e.g., non-clinical) staff on statistical and analysis issues. 
• Lead development of policies and procedures for process improvements and standardization for the department and the statistics group. 
• Attends and contributes to project and department meetings. 

  

Must Have (Minimum Requirements): 

To be considered for this role, the minimum requirements must be evident on your resume.  

• Bachelor's degree  Minimum of 4 years of statistical experience in clinical trial design and data analysis within healthcare  OR Advanced deg