Executive / senior industry position
Location: Remote (preferred locations: Mounds View, MN or Boston, MA)
Careers That Change Lives
Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market. Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentoring, and guidance you need to own your future success. Join us for a career that changes lives.
In this exciting role as a Senior Statistician, you will have primary focus responsibility to perform as a project statistician to support cardiovascular device clinical trials.
Cardiac and Vascular Group (CVG)
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
Cardiac Rhythm and Heart Failure (CRHF) is a business division within CVG which offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.
A Day in the Life
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.
- In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
- Develops and/or applies 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.
- May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
- Prepares the statistical component of protocols, and/or Statistical Analysis Plans which meet project objectives, health authority guidelines, and clinical trial methodology standards. Supports the regulatory review and approval of the experimental therapies.
- Works in a team environment; partners with project teams to support clinical conduct, including collection, management and/or reporting of data.
- Performs statistical analysis utilizing various data sources (e,g., Real-world registry, device recorded diagnostic, therapeutic and performance data logs and meta-analysis, etc.)
- Presents statistical results to non-statisticians, Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
- Complies to good documentation, validation, and other Standard Operation Procedures and requirements.
Must Have (Minimum Requirements):
- Proficient in SAS; Prior experience in FDA and/or global regulatory submissions
- Experience in processing large data
- Experience in handling of protected patient health information
- Demonstrated ability to communicate technical content to non-statisticians (written and verbal)
- Experience writing or updating clinical reports/documents.
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g. ISO, MDD/MDR, CFR)
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Change Begins With You
We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.
The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.
Challenge us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.
Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.
Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.
“The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.”
“Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.”
“Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.”
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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