Senior Statistics Manager - Structural Heart and Aortic
- Bachelor’s degree in Statistics or Biostatistics with a minimum of 7 years of statistics experience with 5+ years of managerial* experience or advanced degree Statistics or Biostatistics with a minimum of 5 years of statistics experience with 5+ years of managerial* experience
*Managerial/leadership experience (i.e., experience as a manager having direct or indirect reports, people leader).
Nice to Have (Preferred Qualifications):
- Master’s degree or PHD degree in Biostatistics, or Statistics and minimum 5 years of statistics experience within medical device industry or pharmaceutical industries
- Experience as a biostatistician in clinical studies from the design through approval stages in the medical device or pharmaceutical industries
- Experience managing/leading statisticians
- Clinical Research statistical support experience at Medtronic or within a medical device industry
- Experience supporting a global team with resources located in different regions or countries
- Strong applied statistical skills, including survival analysis, regression modeling, Bayesian methods, adaptive trial designs, group sequential methods, longitudinal analysis (including mixed models), interim analysis, missing data strategies and multiple testing strategies
- Advanced knowledge of and/or experience with statistical programming packages, including SAS, R, or another statistical analysis package
- Participation in FDA regulatory meetings, especially panel preparation and presentation
- Understanding of dynamic clinical research environment including global regulations and policies
- Project management or business process improvement experience such as Lean Sigma methodology
- Experience developing and maintaining project plans for multiple projects and provide weekly and/or monthly status reporting to upper management
- 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
- Demonstrated ability to communicate technical content to non-statisticians (written and verbal)
- Experience writing or updating clinical reports/documents
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 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).
Travel up to 25% required (primarily domestic and may have some international travel).
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Learn more about our benefits at benefits.medtronic.com
