Principal Statistician

About This Role

This exciting role is responsible for the statistical aspects of study design and data analysis from clinical studies that are conducted for regulatory approval or marketing purposes. This includes study design, sample size and power calculation, writing statistical portions of protocols and analysis plans, and the analysis and interpretation of data. The role suits a statistician who can prepare relevant sections of regulatory submissions, reports, and manuscripts.

Responsibilities

• Design, plan, and execute biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of medical device products
• Use sound statistical methodology to conduct studies relating to the life cycle of the product
• Prepare the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards in development-phase projects
• Develop and/or apply statistical theories, methods, and software
• Summarize and interpret data into tabular and graphical formats amenable to principles of statistical inference and be responsible for the statistical component of reports describing studies, outcomes, and methods used
• Provide specifications and directions to the clinicians/statistical programmers
• Support 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
• Apply statistical knowledge and experience to the design of clinical studies, ensuring that study objectives can be met
• Identify potential threats to study credibility and validity, and work with the study team to prevent, track, and manage potential problems
• Write the statistical analysis plan for the study
• Perform statistical analysis using statistical programming software (e.g., SAS, R etc.)
• Take 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
• Validate and provide clear documentation of analysis programs
• Write Results and Methods sections of reports and manuscripts as needed
• Consult 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
• Attend and contribute to project and department meetings

Requirements

• Bachelor’s degree required with a minimum of 7 years of statistics (i.e., biostatistics, data analysis) experience or advanced degree with a minimum of 5 years of statistics (i.e., biostatistics, data analysis) experience

Nice to have:

• Master's degree or PhD in Biostatistics, Statistics, or equivalent
• 7+ 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
• 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)
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required

Benefits

• Medtronic Incentive Plan (MIP)
• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Important Details

• U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above

About the Company

Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Its 95,000 employees work across more than 150 countries to put patients first, developing innovative medical technologies that improve the lives of over 72 million patients each year. Its Surgical Operating Unit brings together the people and product portfolio of Surgical Innovations and Surgical Robotics.