Senior Statistician.

Senior Statistician Surgical

In 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

Careers That Change Lives

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.

Operating Unit

Our Surgical OU is one new, powerful operating unit bringing together the people and product portfolio of Surgical Innovations and Surgical Robotics.

We’ll approach the market with a unified approach from concept single strategy, capitalize on our global commercial capabilities, and prove the power of our combined portfolio.

With the Medtronic Mission as our North Star, we will build on our legacy of proven surgical solutions and advance the promise of robotics and digital solutions for the benefit of Medtronic and the customers and patients we serve.

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 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

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
30+ days ago