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Senior Principal Statistician

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Clinical
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20000E2E 충원요청 번호

Location: Minneapolis, MN

 

Careers that Change Lives

 

Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market.

 

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 CRHF and CAS development pipeline, the Sr. Principal Statistician will provide advanced statistical expertise, innovative problem solving, and leadership to the CRHF and CAS clinical organizations 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.   

 
CVG

The Cardiac and Vascular Group (CVG) 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. This group includes Aortic, Peripheral and Venous (APV), Cardiac Rhythm and Heart Failure (CRHF), Atrial Fibrillation (AF) Solutions, and Coronary and Structural Heart products.

 

Within CVG, the Cardiac Rhythm and Heart Failure (CRHF) offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions. The Cardiac Ablation Solutions (CAS) division provides a broad suite of electrophysiology solutions intended to disrupt and lead the market in cardiac mapping and ablation technologies for arrhythmia management. These clinical and economical solutions will enable clinicians to treat patients with safer, faster and easier, and with more predictable procedure times and outcomes.

 

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.
  • 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.

Must Have (Minimum Requirements):

To be considered for this role, the minimum requirements must be evident on your resume. 

  • Bachelor’s degree and minimum 10 years of experience in statistics (e.g., biostatistics and/or statistical data analysis) or advanced degree with a minimum of 8 years of experience in statistics (e.g., biostatistics and/or statistical data analysis)

Nice to Have (Desired/Preferred Qualifications):

  • Extensive experience in the design and successful execution of large, global, and pivotal premarket clinical trials
  • Advanced degree (in Statistics, Biostatistics, or related field (e.g., Medicine, Mathematics, Epidemiology, Biology/Biochemistry
  • Experience in clinical trial design
  • Strong applied statistics experience (e.g., survival analysis, regression modeling, interim analyses, missing data strategies, longitudinal analyses).
  • Excellent communication skills, including:
    • Ability to explain complex statistical and clinical study concepts in plain, clear language.
    • Ability and prior experience in presenting, influencing and fielding questions from Regulatory bodies, KOL physicians, and senior executives.
    • Ability to share statistical techniques and coach junior statisticians.
  • Specialized training and experience with adaptive designs, Bayesian hierarchical models, design of experiments,  group sequential designs, multiple testing strategies, epidemiology, Meta-Analysis, data mining, or statistical sampling.
  • High level of knowledge of clinical trial methods and execution in a regulated environment
  • Analysis of data from clinical studies or design of clinical trials.
  • Experience at Medtronic or in the medical device industry
  • Programming skills with major/commonly used statistical applications (e.g., SAS, R)
  • Experience managing/leading people and teams.
  • Research and application experience equivalent to a tenured Associate Professor of Biostatistics at a major research institution.
  • Experience applying Bayesian methods to clinical trials.
  • Ability to develop and apply innovative statistical methods to support Value Based Healthcare models and frameworks for Benefit/Risk profiles of medical devices.
  • Experience supporting a global clinical research and medical affairs organization, with clinical studies in Asia Pacific, Europe, Latin America, North America.
  • Experience in developing and interacting with Data Safety Monitoring Boards, Adverse Events Committees, and Clinical Events Committees.
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure timely delivery.
  • High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel, PowerPoint). 
 

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 20%. Must be able to travel independently including various Medtronic buildings/sites.

 
Check out benefits.medtronic.com

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