Prin Statistician

Medtronic•North Haven, MN

About The Position

In this exciting role as Principal 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. 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. 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.

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 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 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.

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.
In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
Develops and/or 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.
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.)
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.
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.
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)