Principal Statistician - Peripheral Vascular Health
Principal Statistician - Peripheral Vascular Health
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$ 143200 - 214800
1 Vacancy
Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
Careers That Change Lives
In this exciting role as aPrincipal Statistician you will have primary focus responsibilityfor statistical aspects of study design and analysis of data from complex 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.
Peripheral Vascular Health Operating Unit
Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio treating patients with a broad range of conditions including Peripheral and Carotid Disease End Stage Renal Disease Peripheral Embolization and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies.
We believe that when people from different cultures genders and points of view come together innovation is the result and everyone wins. Medtronic walks the walk creating an inclusive culture where you can thrive. To learn more about Inclusion & Diversity at MedtronicClick Here
Ability to travel up to 10%(primarily domestic and may have some international travel).
A Day in the Life
Responsibilitiesmay include the following and other duties may be assigned.
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 pharmaceutical and/or biological products.
Uses sound statistical methodology to conduct studies relating to the life cycle of the product.
Oversight of statistical support and deliverables for ensuring adherence to study specific requirements as well as consistent applications of relevant methods across the portfolio.
In development-phase projects prepares the statistical component of protocols which meet project objectives health authority guidelines and clinical trial methodology standards.
Research develop and/or applies novel 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.
Partner in trial design and in establishing standards for clinical conduct and the collection management and/or reporting of data.
Other responsibilities:
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.
Assists in development and review of case report forms ensuring data will be collected efficiently and accurately.
Identifies potential threats to study credibility validity and data integrity and works with study team to prevent track and manage potential problems.
Writes the statistical analysis plan for the study.
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.
Uses a variety of statistical methods and software tools to analyze and display data from clinical and other studies including more advanced methods. Methods must be appropriate for the kind of data collected and assumptions must be tested.
Validates and provides clear documentation of analysis programs.
Writes Results and Methods sections of reports and manuscripts as needed and ensures interpretation of statistical and clinical findings in regulatory submissions reports and manuscripts accurately reflect the data collected.
Consults with other (e.g. non-clinical) staff on statistical and analysis issues.
Lead development for process improvements and standardization for the department and the statistics group.
Attends and contributes to project and department meetings.
Demonstrates excellent collaboration and interpersonal skills.
Must Have (Minimum Requirements):
To be considered for this role the minimum requirements must be evident on your resume.
Bachelors degree
Minimum of 7 years of statistical experience in clinical trial design and data analysis within healthcare
OR
Advanced degree with a minimum of 5 years of statistical experience in clinical trial design and data analysis within healthcare
Nice to Have (Preferred Qualifications):
Masters degree or PHD degree in Biostatistics or Statistics and minimum 8 years of statistics experience within medical device industryor pharmaceutical industries
Experience as a biostatistician in clinical studies from the design through approval stages in the medical deviceor pharmaceutical industries
Strong applied statistical skills includingsurvival analysis regression modelingadaptive trial designsgroup sequential methods longitudinal analysis (including mixed models) interim analysis Bayesian methods missing data strategies and multiple testing strategies
Advanced knowledge of and/or experience withstatistical programming packages including SAS R or another statistical analysis package
Participation inFDA PMDA or otherregulatory meetings especially panel preparation and presentation
Experience inGood Clinical Practice (GCP)and/or regulatory compliance guidelines for clinical trialsand medical devices ( MDD/MDR)
High level of knowledge of clinical trial methods and execution
High degree of expertise regarding research data management
High level of competency in Windows environment and with Microsoft Office Tools (Word Excel)
Demonstrated ability to communicate technical content to non-statisticians (written and verbal)
Experience writing or updating clinical reports/documents
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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
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. (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.Learnmore about our benefitshere.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP)here.
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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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 95000 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 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 findhere 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.
Required Experience:
Staff IC
Employment Type
Full-Time
