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Senior Principal Statistician - Peripheral Vascular Health (Remote within the U.S.; Mounds View, MN preferred)

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Clinical
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21000DLE 충원요청 번호
Careers That Change Lives
Due to the ever-changing global regulatory landscape and increasing need for innovative approaches to utilize clinical trial statistical resources to fulfill regulatory requirements and produce real world clinical evidence from the complexity of new products in Medtronic’s Peripheral Vascular Health (PVH) development pipeline, the Sr. Principal Statistician will provide advanced statistical expertise, innovative problem solving, and leadership to the PVH clinical organization for continued business success. This position is primarily responsible for providing statistical leadership on a broad range of clinical studies and within the functional team. This role will report to the Statistics Director.

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.

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. To learn more about Inclusion & Diversity at Medtronic Click Here 

Location: Remote within the U.S. (preferred location: Mounds View, MN
Ability to travel up to 15% (primarily domestic and may have some international travel).

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.

Key responsibilities:

  • Leads or provides statistical input for more than one indication, including review with upper management.
  • Leads clinical study statistical design.
  • Leads analysis planning for clinical studies.
  • Leads in determination of algorithm and data handling rules with clinical and programming. Provides table shells and programming specifications.
  • Assists or participates in creation of tables and listings for clinical study reports and manuscripts.
  • Performs statistical analysis and ensures accuracy of statistical results.
  • Provides interpretation of data; leads or assists in writing statistical methods and result section for clinical study reports.
  • Provides technical expertise and functional support to clinical study teams and other business areas, such as R&D, marketing, regulatory affairs and medical affairs.
  • Collaborates with the data management group on developing data collection and quality plan.
  • Provides mentoring, coaching, training and/or guidance as required.
  • Participates in the development of department processes and standards.
  • Assists in communicating study results in regulatory submissions, respond to regulatory queries and interact with regulators.
  • Responsible for overseeing statistical aspects of clinical development planning for more than one indication. Expected to be a Clinical Study Team member for more than one team.
  • Provides statistical leadership to clinical areas of project development. Responsible for the appropriateness of statistical methods and accuracy of results for all aspects of the project.
  • Participates in the design of protocols and preparation of statistics section of protocols.
  • Creates or reviews statistical analysis plan, table shells and programming specifications, and analysis data dictionary.
  • Reviews and approves clinical case report forms, clinical database specifications, data quality plan, data requests, etc., and participates in data management activities per SOPs.
  • Serves as a contact with outside investigators in the preparation of scientific presentations and manuscripts.
  • Ensures compliance with department SOP’s and regulatory guidance.
  • Participation in FDA regulatory meetings, especially panel preparation and presentation
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume. 
  • Bachelor’s degree in Biostatistics/Statistics, Epidemiology or Mathematics and minimum 10 years of experience in statistics and/or data analysis within clinical/healthcare, or advanced degree in Biostatistics/Statistics, Epidemiology or Mathematics with a minimum of 8 years of experience in statistics and/or data analysis within clinical/healthcare

Nice to Have (Desired/Preferred Qualifications):

  • Advanced degree in Statistics, Biostatistics, or related field (e.g., Medicine, Mathematics, Epidemiology, Biology/Biochemistry and minimum 8 years of statistics experience within medical device industry or pharmaceutical industries
  • Experience at Medtronic or in the medical device/pharmaceutical industry as a Biostatistician in clinical studies from the design through approval stages with expertise in clinical trial methods and execution
  • Experience supporting a global clinical research and medical affairs organization, with clinical studies in Asia Pacific, Europe, Latin America, North America
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g. ISO, MDD/MDR)
  • 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
  • Ability to develop and apply innovative statistical methods to support Value Based Healthcare models and frameworks for Benefit/Risk profiles of medical devices.

 

  • Experience managing/leading people and teams.
  • High degree of expertise regarding research data management
  • Experience writing or updating clinical reports/documents
  • Research and application experience equivalent to a tenured Associate Professor of Biostatistics at a major research institution.
  • Experience in developing and interacting with Data Safety Monitoring Boards, Adverse Events Committees, and Clinical Events Committees.
  • Demonstrated ability to communicate technical content to non-statisticians (written and verbal)
  • Excellent communication skills, including:
    • Ability to explain complex statistical and clinical study concepts in plain, clear language.
    • Ability to present well and field questions from Regulatory bodies, KOL physicians, and senior executives.
    • Ability to share statistical techniques and coach junior statisticians.
  • High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel)
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure timely delivery.

 

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)

 

Ability to travel up to 15% (primarily domestic and may have some international travel).

Must be able to travel independently to various Medtronic buildings/sites.

 

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

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