Principal Statistician at Medtronic in Boulder, Colorado

Job Description:

We anticipate the application window for this opening will close on - 3 Jan 2025

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
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.

Location: Boulder, CO or Mounds View, MN (hybrid)

Responsibilities may include the following and other duties may be assigned.

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  • 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.
  
  
  
  
  • P artner s 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 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. Also writes and validates error-checking requirements for the study data.
  
  
  
  
  • 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 , as well as in response to journal reviewer feedback.
  
  
  
  
  • 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.
  
  

• 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 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 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

Physical Job Requirements

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
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):$139,200.00 - $208,800.00

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).

The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Further details are available at the following link: https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic

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).

The following benefits and additional compensation are available to all regular employees: 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) , and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here .

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.