Sr Biostatistician

Medtronic is a global leader in healthcare technology, dedicated to alleviating pain and restoring health. They are seeking a Senior Biostatistician to lead the statistical aspects of study design and data analysis for clinical studies aimed at regulatory approval and marketing. The role involves designing studies, analyzing data, and preparing reports for regulatory submissions.

Responsibilities:

• Designs, plans and executes biostatistical components of plans for clinical 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 and/or 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
• 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
• Identifies potential threats to study credibility and validity, 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
• 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