Medtronic
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We anticipate the application window for this opening will close on – 31 Oct 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
SENIOR STATISTICIAN
For over a decade, Medtronic has been at the forefront of transforming stroke care, leading the fight against both acute ischemic stroke (AIS) and hemorrhagic stroke. By equipping physicians with innovative technologies, we empower their expertise to improve patient outcomes and redefine neurovascular care. Our commitment extends beyond medical device development—we actively collaborate with the medical community to drive meaningful advancements in stroke treatment. Together, we are changing the way stroke is managed worldwide, making a lasting difference for the millions of patients affected every day. Join a diverse team of innovators who bring their worldview, unique backgrounds, and individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. Responsibilities
Design and Execute biostatistical components of research and development projects essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Use sound statistical methodology to conduct studies throughout the product lifecycle. Oversee statistical support and deliverables to ensure adherence to study‑specific requirements and consistent application of relevant methods across the portfolio. Prepare the statistical component of protocols that meet project objectives, health authority guidelines, and clinical trial methodology standards. Research, develop, and apply novel statistical theories, methods, and software. 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. Provide specifications and directions to clinicians/statistical programmers. Support the regulatory review and approval of experimental therapies. Partner in trial design and establish standards for clinical conduct, data collection, management, and reporting. Other Responsibilities
Apply statistical knowledge to the design of clinical studies, ensuring that study objectives can be met, including the calculation of sample size and power. Assist in the development and review of case report forms to ensure efficient and accurate data collection. Identify potential threats to study credibility, validity, and data integrity, working with the study team to prevent, track, and manage problems. Write the statistical analysis plan for the study, if required. Lead the response to questions from FDA, FDA Advisory Panels, and other regulatory agencies, and in negotiations regarding study design and interpretation. 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. Validate and provide clear documentation of analysis programs. Write Results and Methods sections of reports and manuscripts as needed, ensuring accurate interpretation of statistical and clinical findings in regulatory submissions. Consult with non‑clinical staff on statistical and analysis issues. Lead the development of policies and procedures for process improvements and standardization for the department and statistics group. Attend and contribute to project and department meetings. To Be Successful in This Role
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. 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, interim analysis, Bayesian methods, and multiple testing strategies. Advanced knowledge and/or experience with statistical programming packages, including SAS, R, or another statistical analysis package. Participation in FDA, PMDA, or other regulatory meetings, including panel preparation and presentation. Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices. High degree of expertise regarding research data management. Demonstrated ability to communicate technical content to non‑statisticians (written and verbal). High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel). Must Have: Minimum Requirements
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. Nice To Have: Preferred Qualifications
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. Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. Salary ranges for U.S. (excl. PR) locations: $118,400 – $177,600. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). Regular employees receive health, dental, vision insurance, Health Savings Account, Flexible Spending Account, Life insurance, Long‑term disability leave, Dependent daycare spending account, Tuition assistance, and Simple Steps (global well‑being program). Employees also have incentive plans, 401(k) plan with employer match, Short‑term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non‑qualified Retirement Plan Supplement, Capital Accumulation Plan, and additional benefits for all full‑time roles. About Medtronic
Medtronic benefits and compensation plans. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity. 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. 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, 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. Referrals increase your chances of interviewing at Medtronic by 2x Get notified about new Senior Statistician jobs in Irvine, CA.
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SENIOR STATISTICIAN
For over a decade, Medtronic has been at the forefront of transforming stroke care, leading the fight against both acute ischemic stroke (AIS) and hemorrhagic stroke. By equipping physicians with innovative technologies, we empower their expertise to improve patient outcomes and redefine neurovascular care. Our commitment extends beyond medical device development—we actively collaborate with the medical community to drive meaningful advancements in stroke treatment. Together, we are changing the way stroke is managed worldwide, making a lasting difference for the millions of patients affected every day. Join a diverse team of innovators who bring their worldview, unique backgrounds, and individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. Responsibilities
Design and Execute biostatistical components of research and development projects essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Use sound statistical methodology to conduct studies throughout the product lifecycle. Oversee statistical support and deliverables to ensure adherence to study‑specific requirements and consistent application of relevant methods across the portfolio. Prepare the statistical component of protocols that meet project objectives, health authority guidelines, and clinical trial methodology standards. Research, develop, and apply novel statistical theories, methods, and software. 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. Provide specifications and directions to clinicians/statistical programmers. Support the regulatory review and approval of experimental therapies. Partner in trial design and establish standards for clinical conduct, data collection, management, and reporting. Other Responsibilities
Apply statistical knowledge to the design of clinical studies, ensuring that study objectives can be met, including the calculation of sample size and power. Assist in the development and review of case report forms to ensure efficient and accurate data collection. Identify potential threats to study credibility, validity, and data integrity, working with the study team to prevent, track, and manage problems. Write the statistical analysis plan for the study, if required. Lead the response to questions from FDA, FDA Advisory Panels, and other regulatory agencies, and in negotiations regarding study design and interpretation. 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. Validate and provide clear documentation of analysis programs. Write Results and Methods sections of reports and manuscripts as needed, ensuring accurate interpretation of statistical and clinical findings in regulatory submissions. Consult with non‑clinical staff on statistical and analysis issues. Lead the development of policies and procedures for process improvements and standardization for the department and statistics group. Attend and contribute to project and department meetings. To Be Successful in This Role
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. 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, interim analysis, Bayesian methods, and multiple testing strategies. Advanced knowledge and/or experience with statistical programming packages, including SAS, R, or another statistical analysis package. Participation in FDA, PMDA, or other regulatory meetings, including panel preparation and presentation. Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices. High degree of expertise regarding research data management. Demonstrated ability to communicate technical content to non‑statisticians (written and verbal). High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel). Must Have: Minimum Requirements
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. Nice To Have: Preferred Qualifications
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. Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. Salary ranges for U.S. (excl. PR) locations: $118,400 – $177,600. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). Regular employees receive health, dental, vision insurance, Health Savings Account, Flexible Spending Account, Life insurance, Long‑term disability leave, Dependent daycare spending account, Tuition assistance, and Simple Steps (global well‑being program). Employees also have incentive plans, 401(k) plan with employer match, Short‑term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non‑qualified Retirement Plan Supplement, Capital Accumulation Plan, and additional benefits for all full‑time roles. About Medtronic
Medtronic benefits and compensation plans. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity. 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. 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, 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. Referrals increase your chances of interviewing at Medtronic by 2x Get notified about new Senior Statistician jobs in Irvine, CA.
#J-18808-Ljbffr