Posted:
3/13/2025, 5:00:00 PM
Location(s):
Colorado, United States ⋅ Boulder, Colorado, United States ⋅ Mounds View, Minnesota, United States ⋅ Minnesota, United States
Experience Level(s):
Expert or higher ⋅ Senior
Field(s):
Data & Analytics
Workplace Type:
Hybrid
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.
Responsibilities may include the following and other duties may be assigned.
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. 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.
Required Knowledge and Experience:
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.
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.
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
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 95,000+ 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.
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Website: https://www.medtronic.com/
Headquarter Location: Mumbai, Maharashtra, India
Employee Count: 1001-5000
Year Founded: 1979
IPO Status: Private
Industries: Health Care ⋅ Manufacturing ⋅ Medical Device