Senior Statistician, Surgical

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the LifeIn this exciting role as Senior Statistician, 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.

Location: Minneapolis, MN preferred; open to remote within the U.S., minimal amounts of travel as required

Responsibilities may include the following and other duties may be assigned.

• Designs, plans and executes biostatistical components of plans for clinical 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. 
• 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.
• Demonstrates excellent collaboration and interpersonal skills.

Must Have: Minimum Requirements
 

• Bachelor’s degree with 4 years of statistics experience

OR

• An advanced degree with 2 years of statistics experience

Nice to Have

• Master's degree or PhD in biostatistics or statistics
• 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.
• Previous experience with Medtronic
• 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.
• Strong attention to detail

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.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
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.
 

Salary ranges for U.S (excl. PR) locations (USD):$116,000.00 - $174,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

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.

At Medtronic, most positions are posted on our career site for 3-7 days. 

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