Qualifications
Responsibilities
Benefits
In this exciting role as a Senior Statistician, you will be responsible for statistical aspects of study design, study execution, 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 the statistical portions of protocols and statistical analysis plans, review of protocol and case report forms, analysis, including statistical programming, 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.
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 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/statistical programmers.
Supports the regulatory review and approval of the experimental therapies.
Partner in trial design and in establishing standards for clinical trial 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 properly assessed. 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.
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 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.
Attends and contributes to project and department meetings.
Demonstrates excellent collaboration and interpersonal skills.
Must Have (Minimum Requirements):
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelor's degree
Minimum of 4 years of statistical experience in clinical trial design and data analysis within healthcare
Advanced degree with a minimum of 2 years of statistical experience in clinical trial design and data analysis within healthcare
Nice to Have (Preferred Qualifications):
Master’s degree or PHD degree in Biostatistics, or Statistics
Experience as a biostatistician in clinical studies from the 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 (including mixed models), interim analysis, Bayesian methods, missing data strategies and multiple testing strategies
Experience writing or updating clinical reports/documents
Advanced knowledge of and/or experience with statistical programming packages, including SAS and R
Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, 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)
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
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.
U.S. Work Authorization & Sponsorship
At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
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