Sr. Principal Statistician - Hybrid, Mounds View, MN.

Careers That Change Lives

In this exciting role as a Sr. Principal Statistician, you will have primary focus responsibility for leading statistical aspects of study design and data analysis from research clinical studies conducted for concept feasibility.

This includes designing studies, calculating sample size and power, writing statistical portions of protocols and statistical analysis plans, reviewing study protocols and case report forms, analyzing and interpreting data, and preparing relevant sections of regulatory submissions, reports, and manuscripts.

Additionally, as a critical member of the Research and Technology team, you will collaborate with scientists and engineers to generate clinical evidence by testing hypotheses using both internal device collected data and external clinical data.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day.

We work hard to cultivate a workforce that reflects our patients and partners because we believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Cardiac Rhythm Management (CRM) :

Cardiac Rhythm Management (CRM) focuses on developing and delivering innovative solutions for diagnosing, treating, and managing heart rhythm disorders and heart failure.

CRM offers a range of products and software that help patients live longer and healthier lives.

A Day in the Life

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 biological 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.
• Develops and / or applies 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.
• May 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, please ensure the minimum requirements are evident on your resume) :

Bachelor’s Degree with 10+ years of work experience in Engineering OR Advanced degree in Engineering or technical field with 8+ years of statistical experience in clinical trial design and data analysis within healthcare

Nice to Have

• Master’s degree or PHD degree in Biostatistics, or Statistics and minimum 10 years of statistics experience within medical device industry or pharmaceutical industries
• 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
• Advanced knowledge of and / or experience with statistical programming packages, including SAS, R, or another statistical analysis package
• Participation in FDA, PMDA or other regulatory meetings, especially panel preparation and presentation
• 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)
• Experience writing or updating clinical reports / documents
30+ days ago