Medtronic plc
* **Design and Execution:** Design, plan, and execute biostatistical components of research and development projects essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products.* **Methodology Application:** Use sound statistical methodology to conduct studies throughout the product lifecycle.* **Oversight of Deliverables:** Oversee statistical support and deliverables to ensure adherence to study-specific requirements and consistent application of relevant methods across the portfolio.* **Protocol Preparation:** In development-phase projects, prepare the statistical component of protocols that meet project objectives, health authority guidelines, and clinical trial methodology standards.* **Novel Methodologies:** Research, develop, and apply novel statistical theories, methods, and software.* **Data Interpretation:** Summarize and interpret data into tabular and graphical formats amenable to statistical inference, responsible for the statistical component of reports describing studies, outcomes, and methods used.* **Collaboration:** Provide specifications and directions to clinicians/statistical programmers.* **Regulatory Support:** Support the regulatory review and approval of experimental therapies.* **Trial Design Partnership:** Partner in trial design and establish standards for clinical conduct, data collection, management, and reporting.* **Study Design Expertise:** Apply statistical knowledge to the design of clinical studies, ensuring that study objectives can be met, including the calculation of sample size and power.* **Case Report Form Development:** Assist in the development and review of case report forms to ensure efficient and accurate data collection.* **Credibility Management:** Identify potential threats to study credibility, validity, and data integrity, working with the study team to prevent, track, and manage problems.* **Statistical Analysis Plan:** Write the statistical analysis plan for the study, if required.* **Regulatory Agency Interaction:** Take a leadership role in responding to questions from FDA, FDA Advisory Panels, and other regulatory agencies, and in negotiations regarding study design and interpretation.* **Data Analysis Tools:** Use a variety of statistical methods and software tools to analyze and display data from clinical studies, ensuring methods are appropriate for the data collected.* **Documentation Validation:** Validate and provide clear documentation of analysis programs.* **Report Writing:** Write Results and Methods sections of reports and manuscripts as needed, ensuring accurate interpretation of statistical and clinical findings in regulatory submissions.* **Consultation:** Consult with non-clinical staff on statistical and analysis issues.* **Process Improvement:** Lead the development of policies and procedures for process improvements and standardization for the department and statistics group.* **Team Contribution:** Attend and contribute to project and department meetings.* **Medical Device Experience:** Experience as a biostatistician in clinical studies from design through approval stages in the medical device or pharmaceutical industries.* **Applied Statistical Skills:** Strong applied statistical skills, including survival analysis, regression modeling, adaptive trial designs, group sequential methods, longitudinal analysis (including mixed models), interim analysis, Bayesian methods, and multiple testing strategies.* **Statistical Programming Proficiency:** Advanced knowledge of and/or experience with statistical programming packages, including SAS, R, or another statistical analysis package.* **Regulatory Interaction:** Participation in FDA, PMDA, or other regulatory meetings, including panel preparation and presentation.* **GCP and Compliance Knowledge:** Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR).* **Research Data Management:** High degree of expertise regarding research data management.* **Communication Skills:** Demonstrated ability to communicate technical content to non-statisticians (written and verbal).* **Technical Proficiency:** High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel).**Statistical Experience:** Minimum of **4 years** of statistical experience in clinical trial design and data analysis within healthcare, or an advanced degree with **2 years** of experience.Bachelor’s degree in a relevant field with a minimum of **4 years** of statistical experience in clinical trial design and data analysis within healthcare, or an advanced degree with a minimum of **2 years** of experience.* Master’s degree or PhD in Biostatistics or Statistics with a minimum of **8 years** of statistics experience within the medical device or pharmaceutical industries.* Strong history of successful contributions to clinical studies, including designing and executing statistical plans.**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.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
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.* **Build** a better future, amplifying your impact on the causes that matter to you and the world* **Grow** a career reflective of your passion and abilities* **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learningThese commitments set our team apart from the rest:**Experiences that put people first**. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.**Life-transforming technologies**. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live #J-18808-Ljbffr
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.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
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.* **Build** a better future, amplifying your impact on the causes that matter to you and the world* **Grow** a career reflective of your passion and abilities* **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learningThese commitments set our team apart from the rest:**Experiences that put people first**. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.**Life-transforming technologies**. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live #J-18808-Ljbffr