Principal Statistician - Cardiac Rhythm Management - Medtronic

We anticipate the application window for this opening will close on - 18 Nov 2024At 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 LifeThe Principal Statistician will work on CRM or CAS clinical trial to support market approval and adoption of Medtronic advanced cardiac device therapies.In this exciting role as a Principal Statistician, you will have primary focus responsibility for statistical aspects of study design and analysis of data from complex clinical studies conducted for regulatory approval or clinical evidence generation  purposes.  This includes responsibility for design of clinical studies, calculating  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 often will be in a team environment, and will be reviewed key stakeholdersThough Mounds View, MN is the preferred location, this role can be remote-based, located anywhere in the U.S.  .Ability to travel up to 10% (primarily domestic and may have some international travel).Role and Responsibilities:Responsibilities may 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, if required. 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 required 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 of policies and procedures for process improvements and standardization for the department and the statistics group.Attends and contributes to project and department meetings.Must Have (Minimum Requirements):To be considered for this role, the minimum requirements must be evident on your resume. Bachelor's 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 healthcareNice to Have (Preferred Qualifications):Master’s degree or PHD degree in Biostatistics, or Statistics and minimum 8 years of statistics experience within medical device industry or pharmaceutical industriesIntrinsic curiosity and keen interest in medical researchExperience as a biostatistician in clinical studies from the design through approval stages in the medical device or pharmaceutical industriesStrong applied statistical skills, including survival analysis, regression modeling, adaptive trial designs, group sequential methods, longitudinal analysis (including mixed models), interim analysis, Bayesian methods, missing data strategies and multiple testing strategiesAdvanced knowledge of and/or experience with statistical programming packages, including SAS, R, or another statistical analysis packageExperience in handling large complex datasetParticipation in FDA, PMDA or other regulatory meetings, especially panel preparation and presentationExperience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR)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/documentsPhysical Job RequirementsThe 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 & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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.Salary ranges for U.S (excl.
PR) locations (USD):$139,200.00 - $208,800.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California.
The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.
Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).Medtronic benefits and compensation plansAbout MedtronicWe 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 90,000+ 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.SummaryLocation: Mounds View, Minnesota, United States of AmericaType: Full time