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Clinical
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20000EXR Requisition #
Location:  Remote (preferred location is Minnesota)
 

Careers That Change Lives

Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market. Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentoring, and guidance you need to own your future success. Join us for a career that changes lives.

 

In this exciting role as a Principal Statistician in the Restorative Therapies Group (RTG), you will have primary focus responsibility for statistical aspects of study design and analysis of data from complex clinical studies conducted for regulatory approval or marketing purposes.  This includes responsibility for design of studies, calculating of sample size and power, writing of statistical portions of protocol and statistical analysis plan, review of protocol and case report forms, analysis and 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.  The Principal Statistician will be expected to provide leadership to study teams and to other statistical staff.

 
RTG

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

 

Within RTG, the Neuromodulation delivers innovative therapies and solutions for neurological diseases, pain, and spasticity.

 
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 for statistical related deliverables.
  • 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. 

Other responsibilities: 

  • Applies statistical knowledge and experience to the design of clinical studies, ensuring that study objectives can be met.  This requires calculation of sample size and power, as well as possible determination of appropriate design assumptions from published literature.
  • Identifies potential threats to study credibility and validity, and works with study team to prevent, track, and manage potential problems.
  • Writes the statistical analysis plan for the study.
  • Takes a leadership role in responding to relevant questions from FDA, FDA Advisory Panels, and/or other regulatory agencies, and in negotiations with regulatory agencies regarding study design and interpretation. 
  • Validates and provides clear documentation of analysis programs.
  • Writes Results and Methods sections of reports and manuscripts as needed.
  • Consults with other (e.g. non-clinical) staff on statistical and analysis issues.
  • Leads development of policies and procedures for the department and the statistics group.
  • Mentors and trains Statisticians and/or Senior Statisticians in their job duties and responsibilities.
  • Attends and contributes to project and department meetings.

Must Have (Minimum Requirements):

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

  • Bachelor’s degree and 7 years of statistics/analysis of data from clinical studies and/or design of clinical trials) experience or advanced degree and years of statistics/analysis of data from clinical studies and/or design of clinical trials)

Nice to Have (Preferred Qualifications):

  • Advanced degree (in Statistics, Biostatistics, or related field (e.g., Medicine, Mathematics, Epidemiology, Biology/Biochemistry
  • Experience in clinical studies from the design through approval stages in the medical device or pharmaceutical industries. 
  • Participation in FDA regulatory meetings, especially panel preparation and presentation. 
  • Strong applied statistical skills, including survival analysis, regression modeling, Bayesian methods, longitudinal analysis (including mixed models), interim analysis, missing data strategies and multiple testing strategies.
  • Advanced programming skills in SAS, or another statistical analysis package; high level of competency in Windows environment and with Microsoft Office Tools (Word, Excel); experience with relational database function, and SAS Proc SQL
  • High level of knowledge of clinical trial methods and execution
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g. ISO, MDD/MDR, CFR)
  • High degree of expertise regarding research data management
  • High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel) 
Competencies:
  • Demonstrated ability to communicate technical content to non-statisticians (written and verbal)
  • Demonstration of good oral and written communication skills
  • Well-developed interpersonal skills and collaborations with multiple functions
  • Demonstration or evidence of leadership competencies.
 

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 10%.

 
Check out benefits.medtronic.com
 

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