Principal Statistician

Medtronic • Boulder, CO

346d • $139,200 - $208,800 • Hybrid

About The Position

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. In this exciting role as Principal Statistician, you will be responsible for providing strategic leadership on the design and analysis of scientific data including, but not limited to, clinical studies and research experiments. Represents Medtronic from a statistical perspective with customers and regulatory bodies. Develops relevant code for data extraction, independently or in collaboration with a programmer, for reporting and analysis purposes according to Medtronic internal requirements. 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.

Requirements

• Bachelor's degree with a minimum of 7 years of statistics (i.e., biostatistics, data analysis) experience OR an advanced degree with a minimum of 5 years of statistics (i.e., biostatistics, data analysis) experience.

Nice To Haves

• 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 time-series analysis.
• 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 global regulatory submissions.
• Participation in FDA and/or Notified Body regulatory meetings, such as panel preparation and presentation, pre-sub (Q-sub) meetings, etc.
• Presents and defends complex statistical solutions to all levels of MDT governance, key stakeholders and external regulatory bodies in a clear, concise, complete, and transparent manner that provides influence on key decisions.
• Demonstrates excellent collaboration and interpersonal skills.
• Demonstrated ability to communicate technical content to non-statisticians (written and verbal).
• Experience in fast-paced working environments.

Responsibilities

• 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.
• Prepares the statistical component of protocols which meet project objectives, regulatory guidelines, international standards, and clinical trial methodology standards.
• Develops and applies statistical theories, methods, and software.
• 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.
• Partners 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.
• 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.).
• Takes a leadership role in responding to relevant questions from FDA, FDA Advisory Panels, and/or other regulatory agencies.
• Validates and provides clear documentation of analysis programs.
• Writes Results and Methods sections of reports and manuscripts as needed and supports Discussion sections.
• Consults with other (e.g., non-clinical) staff on statistical and analysis issues.
• Leads development of policies and procedures for the department and the statistics group.
• Mentors and trains Statisticians and/or Senior Statisticians in their job duties and responsibilities.
• Attends and contributes to project and department meetings.

Benefits

• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Master's degree
• Number of Employees: 5,001-10,000 employees