Careers that change lives
In this exciting role as a senior statistics manager you will have responsibility for providing technical oversight and leadership for the structural heart and aortic (sh&a) biostatistics team, enabling key capabilities in study design, statistical analysis development and execution.
We look for leaders who have a clear vision of where we are going and how to get there, bold inclusive thinkers who create new ideas and bring our best solutions forward to benefit our patients, business partners, and customersThis role reports to the director of statistics in the medtronic structural heart and aortic organizationThe sr statistics manager oversees and directs the work of a global team of statisticians who provide statistical servicesThis role is responsible for providing daily oversight of operations and execution of deliverables as well as to develop and implement strategies to enhance the capabilities and performance of the organization.
The structural heart and aortic integrated operating unit offers minimally-invasive approaches to restore proper structure and function of the heart and the aortaWe focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body’s largest artery, the aorta.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone winsMedtronic walks the walk, creating an inclusive culture where you can thriveJoin a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every dayIt’s no accident — we work hard to cultivate a workforce that reflects our patients and partnersWe believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
To learn more about inclusion & diversity at medtronic click here
This is a remote based role so the candidate can live anywhere in the u.s.
Preferred locations: santa rosa, ca; mounds view, mn
Travel up to 25% required (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 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.
Partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
Drive operational excellence of the biostatistics function across sh&a, focusing on aspects of shared resources and activities.
Coordinate additional statistical and programming support from external vendors, as neededEstablish and maintain relationships with vendors, determine sophistication and volume of support needed, and ensure that accuracy and quality goals are met or exceeded.
Supervise statistical support and deliverables for post approval clinical studies, ensuring appropriate and consistent applications of relevant methods across the portfolio.
Provide strategic consulting with internal teams and external stakeholders for more complex issues being support by the central operations teams.
Provide support plans and cost estimates to clinical study stakeholders for requested support of projects.
Must have (minimum requirements): to be considered for this role, the minimum requirements must be evident on your resume.
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.gIso, 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 worldwideAt medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend lifeWe challenge ourselves and each other to make tomorrow better than yesterdayIt 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 teamLet’s work together to address universal healthcare needs and improve patients’ livesHelp 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 jobReasonable accommodations may be made to enable individuals with disabilities to perform the essential functionsFor office roles: while performing the duties of this job, the employee is regularly required to be independently mobileThe employee is also required to interact with a computer, and communicate with peers and co-workersContact 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 valuesWe recognize their contributionsThey share in the success they help to createWe 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
