Medtronic plc
In this exciting role as Senior Statistician, you will be responsible for statistical aspects of study design and analysis of data from clinical studies conducted for regulatory approval or marketing purposes. 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 but will be reviewed by the Manager at key time points.
* Designs, plans and executes biostatistical components of plans for clinical 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.* In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.* 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 and/or statistical programmers* Supports the regulatory review and approval of the experimental therapies.* May partner 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 possible 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.* Performs statistical analysis using statistical programming software (e.g., SAS, R etc.)* Validates and provides clear documentation of analysis programs.* Writes Results and Methods sections of reports and manuscripts as needed.* Consults with other (e.g., non-clinical) staff on statistical and analysis issues.* Attends and contributes to project and department meetings.* Demonstrates excellent collaboration and interpersonal skills.Bachelor’s degree with **4** years of statistics experienceAn advanced degree with **2** years of statistics experience* Master's degree or PhD in biostatistics or statistics* 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 adaptive designs* 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/or global regulatory submissions.* Demonstrated ability to communicate technical content to non-statisticians (written and verbal).* Demonstration of good oral and written communication skills* Well-developed interpersonal skills and collaborations with multiple functions* Demonstration or evidence of leadership competencies.* Strong attention to detail
**About Medtronic**
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.
**Physical Job Requirements**
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. Learn more about our benefits .
**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 #J-18808-Ljbffr
* Designs, plans and executes biostatistical components of plans for clinical 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.* In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.* 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 and/or statistical programmers* Supports the regulatory review and approval of the experimental therapies.* May partner 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 possible 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.* Performs statistical analysis using statistical programming software (e.g., SAS, R etc.)* Validates and provides clear documentation of analysis programs.* Writes Results and Methods sections of reports and manuscripts as needed.* Consults with other (e.g., non-clinical) staff on statistical and analysis issues.* Attends and contributes to project and department meetings.* Demonstrates excellent collaboration and interpersonal skills.Bachelor’s degree with **4** years of statistics experienceAn advanced degree with **2** years of statistics experience* Master's degree or PhD in biostatistics or statistics* 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 adaptive designs* 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/or global regulatory submissions.* Demonstrated ability to communicate technical content to non-statisticians (written and verbal).* Demonstration of good oral and written communication skills* Well-developed interpersonal skills and collaborations with multiple functions* Demonstration or evidence of leadership competencies.* Strong attention to detail
**About Medtronic**
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.
**Physical Job Requirements**
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. Learn more about our benefits .
**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 #J-18808-Ljbffr