Senior Statistician - Peripheral Vascular
In this exciting role as a Senior Statistician, you will be responsible for statistical aspects of study design, study execution, and analysis of data from clinical studies conducted for regulatory approval or marketing purposes. This includes responsibility for design of studies, calculating of sample size and power, writing the statistical portions of protocols and statistical analysis plans, review of protocol and case report forms, analysis, including statistical programming, interpretation of data, and preparation of relevant sections of regulatory submissions, reports, and manuscripts. Work will generally be self-directed but will be reviewed by the manager at key time points.
Peripheral Vascular Health Operating Unit
Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. To learn more about Inclusion & Diversity at Medtronic Click Here
This role can be remote-based, located anywhere in the U.S.
Preferred locations: Mounds View, MN
Ability to travel up to 10% (primarily domestic and may have some international travel).
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 medical device 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.
- 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 trial conduct, and the collection, management and/or reporting of data.
- Bachelor's degree
- Minimum of 4 years of statistical experience in clinical trial design and data analysis within healthcare
OR
- Advanced degree with a minimum of 2 years of statistical experience in clinical trial design and data analysis within healthcare
Nice to Have
- Master’s degree or PHD degree in Biostatistics, or Statistics
- Experience as a biostatistician in clinical studies from the design through approval stages in the medical device or pharmaceutical industries
- Strong applied statistical skills, including survival analysis, regression modeling, adaptive trial designs, group sequential methods, longitudinal analysis (including mixed models), interim analysis, Bayesian methods, missing data strategies and multiple testing strategies
- Experience writing or updating clinical reports/documents
- Advanced knowledge of and/or experience with statistical programming packages, including SAS and R
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR)
- High level of knowledge of clinical trial methods and execution
- High degree of expertise regarding research data management
- High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel)
- Demonstrated ability to communicate technical content to non-statisticians (written and verbal)
- Well-developed interpersonal skills and collaborations with multiple functions
- Demonstration or evidence of leadership competencies.
- Strong attention to detail
About Medtronic
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 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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).
