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Clinical
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19000IW3 Requisition #
Careers That Change Lives
 
Impact patient outcomes.  Come for a job, stay for a career.
 
The Cardiac and Vascular Group 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.

CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.
 
A Day in the Life
  • 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.
  • Prepares or oversees statistical programming components of regulatory submissions.
  • 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. Is a recognized expert that performs highly-complex programming, reviews Statistical Analysis Plans and Case Report Forms (CRFs), creates statistical report templates, and drives statistical programming 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/statistical programmers. Prepares all SOPs relevant to statistical programming and validation.
  • 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.
Must Have: Minimum Qualifications
  • Bachelors degree required
  • Minimum of 7 years of statistical programming experience, or advanced degree with a minimum of 5 years statistical programming experience
Nice to Have
  • Advanced degree (MS or PhD) in Biostatics or Statistics
  • Participation in FDA regulatory meetings, especially panel preparation and presentation.
  • Strong applied statistical skills, including survival analysis and regression modeling, advanced programming skills in SAS, or another statistical analysis package, high level of knowledge of clinical trial methods and execution, high degree of expertise regarding research data management, high level of competency in Windows environment.
  • High level of knowledge of relational database function, and SAS Proc SQL. Experience with interim analyses, missing data strategies, longitudinal analyses, and other advanced statistical and clinical trial methods
  • Demonstrates strong strategic thinking
  • Navigates complex challenges and solves problems
  • Customer focused
  • Takes ownership and self-motivated
  • Works effectively on cross-functional teams
  • Results and solution oriented
  • Excellent written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
 
Ability to travel up to 10% as needed.
 
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 Day in the Life 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.
 
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.
 
EEO
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
 
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:http://www.uscis.gov/e-verify/employees

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