Principal Statistician - CRDN

Medtronic PlcMinneapolis, MN, US

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Principal Statistician

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.

Coronary and Renal Denervation therapies are a critical part of the Medtronic Cardiovascular portfolio, treating patients with complex conditions, including coronary artery disease and hypertension. We lead the way with recent FDA approved devices caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies. We believe that when people from different cultures, genders, and points of view come together, innovation is the result and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. To learn more about Inclusion & Diversity at Medtronic Click Here 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 role is on-site in Mounds View, MN Ability to travel up to 10% (primarily domestic and may have some international travel).

In this exciting role as a Principal Statistician, you will have primary responsibility for statistical aspects of study design and analysis of data from complex clinical studies conducted for regulatory approval, publications, marketing or reimbursement purposes. This includes responsibility for design of studies, calculating 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, presentations and manuscripts. Work will generally be self-directed but will be reviewed by the Manager at key time points.

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 biomedical, 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.
Research, develop and / or applies novel 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 for 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.

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.

Writes the statistical analysis plan for the study.

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.

Consults with other (e.g., non-clinical) staff on statistical and analysis issues.

Lead development for process improvements and standardization for the department and the statistics group.

Attends and contributes to project and department meetings.

Demonstrates excellent collaboration and interpersonal skills.

Must Have (Minimum Requirements) :

Bachelor's degree

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 Have (Preferred Qualifications) :

Master's degree or PHD degree in Biostatistics, or Statistics and minimum 8 years of statistics experience within the medical device industry or pharmaceutical industries

Experience as a biostatistician in clinical studies from 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 SAS programming skills, and experience with other statistical programming packages, including R.

Participation in FDA, PMDA or other 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

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.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 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)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD) : $143,200.00 - $214,800.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification / education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week : 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 , and Simple Steps (global well-being program).

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Statistician • Minneapolis, MN, US