Principal Statistician - PVH

Medtronic•Mounds View, MN

2d•$146,400 - $219,600•Remote

About The Position

This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 10% of travel to enhance collaboration and ensure successful completion of projects. The preferred location for this role is Mounds View, MN. 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 marketing purposes. This includes responsibility for design of studies, calculating of sample size and power, writing of statistical portions of protocols and statistical analysis plans, review of protocol and case report forms, analysis including statistical programming 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.

Requirements

Bachelor's degree
Minimum of 7 years of statistical experience in clinical trial design and data analysis within healthcare
Advanced degree with a minimum of 5 years of statistical experience in clinical trial design and data analysis within healthcare

Nice To Haves

Master’s degree or PHD degree in Biostatistics, or Statistics and minimum 8 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 and R
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

Responsibilities

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.
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 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.
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.