Principal Statistician

Medtronic•Mounds View, MN

18h•Onsite

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. A Day in the Life Our Cardiac Rhythm Management (CRM) Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of three key businesses including Conduction Pacing Therapy (CPT), Cardiovascular Diagnostics & Services (CDS), and Defibrillation Solutions (DS). We also support Cardiac Ablation Solutions (CAS). Together, we will transform the lives of people with cardiac arrhythmias and heart failure. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This position will be based in Mounds View, MN. 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, calculation 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. Role and Responsibilities: 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. Oversight of statistical support and deliverables for ensuring adherence to study specific requirements as well as consistent applications of relevant methods across the portfolio. In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards. Researches, 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. Partners in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. Other 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. Assists in development and review of case report forms, ensuring data will be collected efficiently and accurately. Identifies potential threats to study credibility, validity, and data integrity and works with study team to prevent, track, and manage potential problems. 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. Validates and provides clear documentation of analysis programs. Writes Results and Methods sections of reports and manuscripts as needed and ensures interpretation of statistical and clinical findings in regulatory submissions, reports, and manuscripts accurately reflect the data collected. Leads development of policies and procedures for process improvements and standardization for the department and the statistics group.

Requirements

Bachelor's degree with a minimum of 7 years of statistical experience in clinical trial design and data analysis within healthcare, OR
Advanced degree with a minimum of 5 years of statistical experience in clinical trial design and data analysis within healthcare

Nice To Haves

Master’s Degree or PhD in statistics/biostatistics
8+ years of statistics experience within medical device industry or pharmaceutical industries
Intrinsic curiosity and keen interest in medical research
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, adaptive trial designs, group sequential methods, longitudinal analysis (including mixed models), interim analysis, Bayesian methods, 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
Experience in handling large complex datasets from various sources
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 pharmaceutical and/or biological products.
Uses sound statistical methodology to conduct studies relating to the life cycle of the product.
Oversight of statistical support and deliverables for ensuring adherence to study specific requirements as well as consistent applications of relevant methods across the portfolio.
In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
Researches, 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.
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.
Assists in development and review of case report forms, ensuring data will be collected efficiently and accurately.
Identifies potential threats to study credibility, validity, and data integrity and works with study team to prevent, track, and manage potential problems.
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.
Validates and provides clear documentation of analysis programs.
Writes Results and Methods sections of reports and manuscripts as needed and ensures interpretation of statistical and clinical findings in regulatory submissions, reports, and manuscripts accurately reflect the data collected.
Leads development of policies and procedures for process improvements and standardization for the department and the statistics group.

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)