Careers that Change Lives

In this exciting role as a Principal Statistician , you will have primary focus responsibility for statistical aspects of study design and analysis of data from complex 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.

Medtronic Corporate Clinical Solutions (MC2) is a trusted industry leader in driving best-in-class, end-to-end clinical and scientific solutions across Medtronic. MC2 provides the resources and expertise to execute strategies for Medtronic clinical studies and other clinical statistical services.

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

This role can be remote-based, located anywhere in the U.S.

Ability to travel up to 10% (primarily domestic and may have some international travel).

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 pharmaceutical and/or biological 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/statistical programmers.
• Supports the regulatory review and approval of the experimental therapies.
• Partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.

Key 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.
• Prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards, including. the plans for data analysis, and justification for the sample size. Reviews entire protocol for consistency.
• Prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
• Assists in development and review of case report forms, ensuring data will be collected efficiently and accurately.
• 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, if required. Also writes error-checking requirements for the study data.
• 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.
• Uses a variety of statistical methods and software tools to analyze and display data from clinical and other studies, including more advanced methods. Methods must be appropriate for the kind of data collected, and required assumptions must be tested.
• Interprets statistical and clinical findings, and ensures that regulatory submissions, reports, and manuscripts accurately reflect the data collected.
• 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.
• Lead development of policies and procedures for the department and the statistics group.
• Mentor and train 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.

• Bachelor’s degree required in Biostatistics, or Statistics and a minimum of 7 years of statistical experience in clinical trial design and/or data analysis within healthcare, or advanced degree with a minimum of 5 years of statistical experience in clinical trial design and/or data analysis within healthcare

Nice to Have

• Master’s degree or PhD degree in Biostatistics or Statistics
• 8+ years of statistics experience in the medical device industry, pharmaceutical industries, or clinical research organizations (CROs)
• Experience as a biostatistician in clinical studies from the design through approval stages in the medical device or pharmaceutical industries
• 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
• Advanced knowledge of and/or experience with statistical programming packages, including SAS, R , or another statistical analysis package
• Participation in FDA regulatory meetings, especially panel preparation and presentation
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR )
• 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 and with Microsoft Office Tools (Word, Excel)
• Demonstrated ability to communicate technical content to non-statisticians (written and verbal)
• Experience writing or updating clinical reports/documents

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 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)