Senior Statistician, Neuromodulation and Pelvic Health

Clinical       ·       Remote in Minneapolis, MN       ·       Full time

Careers That Change Lives

In this exciting role as the Senior 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.

We’re 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. 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:  Minneapolis, 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.
• 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 and/or 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.)
• 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.
• 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 required with a minimum of 4 years of statistics (i.e., biostatistics, data analysis) experience or advanced degree with a minimum of 2 years of statistics (i.e., biostatistics, data analysis) experience

Nice to Have (Preferred Qualifications):

• Master’s degree or PhD in Biostatistics/Statistics
• 4+ years of post-graduate statistical experience
• Experience in analysis of data from clinical studies and design of clinical trials
• 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.
• Experience with adaptive designs
• Advanced knowledge of and/or experience with statistical 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 trials and medical devices (e.g., ISO, MDD/MDR).
• Prior experience in FDA and/or global regulatory submissions.
• 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 % (domestically and internationally)

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 

Travel: Yes, < 25 % of the Time

Please click here to apply.