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Principal Statistician, Neuromodulation (MN or Remote within the U.S.)

Medtronic
Boston, MA 02133 Work Remotely
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Principal Statistician, Neuromodulation (MN or Remote within the U.S.)

Location:

Rice Creek, Minnesota, United States

Requisition #:

220004NM

Post Date:

Mar 01, 2022


**Careers That Change Lives**


In this exciting role as the Principal biostatistician,you will be responsible for statistical aspects of study design and analysis of data from 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.


Our vision is to become the undisputed world leader in Neuromodulation, improving patient lives through innovative solutions. Our therapies span the care continuum; from early interventional procedures to implantable surgical technologies that relieve pain, restore function and improve lives for our patients.


Were committed to applying clinical and economic evidence and integrated technologies to our unmatched portfolio of therapies to develop healthcare solutions that increase patient access, improve the efficiency of procedures and deliver successful patient outcomes.


Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.To learn more about Inclusion Diversity at MedtronicClick Here (https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html)


Location: Rice Creek, MN preferred; open to Remote in the U.S.


Ability to travel up to 10 **%** (domestically and internationally)


**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.

+ 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.


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.

+ Performs statistical analysis using statistical programming software (e.g., SAS, R etc.)

+ 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.**


+ Bachelors degree required with a minimum of **7** years of statistics (i.e., biostatistics, data analysis) experienceor advanced degree with a minimum of **5** years of statistics (i.e., biostatistics, data analysis) experience


**Nice to Have (Preferred Qualifications):**


+ Masters degree or PhD in Biostatistics/Statistics

+ 7+ years of post-graduate statistical experience

+ Experience at Medtronic or in themedical device industry with a background in Neuroscience/Neuromodulation

+ Experience in analysis of data from clinical studies and design of clinical trials

+ Strong applied statistical skills, includingsurvival 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.

+ Experience with adaptive designs

+ Advanced knowledge of and/or experience withstatistical programming packages, including SAS, R, or another statistical analysis package.

+ Experience communicating complex statistical/machine learning results to technical and non-technical through journal publications, conferences, presentations/posters, and seminars

+ High level of knowledge of clinical trial methods and execution.

+ Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trialsand medical devices (e.g., ISO, MDD/MDR).Prior experience in FDA and/or global regulatory submissions.

+ Participation in FDA regulatory meetings, especially panel preparation and presentation Experience writing or updating clinical reports/documents.

+ Demonstrated ability to communicate technical content to non-statisticians (written and verbal).


**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. Lets 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).


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**
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.

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Posted: 2022-03-08 Expires: 2022-06-10
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Principal Statistician, Neuromodulation (MN or Remote within the U.S.)

Medtronic
Boston, MA 02133

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