Prin Statistician - Exempt

Join our dynamic team in Mounds View, MN, where you will play a pivotal role in shaping the future of medical device products through advanced statistical analysis and clinical research. While local candidates are preferred, remote work is an option for the right candidate.

• Design, plan, and execute biostatistical components of research and development projects to determine the safety, efficacy, and marketability of medical device products.
• Utilize sound statistical methodology to conduct studies related to the product life cycle.
• Prepare the statistical component of protocols in development-phase projects, ensuring alignment with project objectives, health authority guidelines, and clinical trial methodology standards.
• Develop and/or apply statistical theories, methods, and software.
• Summarize and interpret data into tabular and graphical formats for statistical inference; responsible for the statistical component of reports describing studies, outcomes, and methods used.
• Provide specifications and directions to clinicians/statistical programmers.
• Support the regulatory review and approval of experimental therapies.
• Partner in trial design and establish standards for clinical conduct, data collection, management, and reporting.
• Identify potential threats to study credibility and validity, working with the study team to prevent, track, and manage potential problems.
• Write the statistical analysis plan for studies.
• Perform statistical analysis using statistical programming software (e.g., SAS, R, etc.).
• Lead responses to relevant questions from FDA, FDA Advisory Panels, and/or other regulatory agencies, and participate in negotiations regarding study design and interpretation.
• Validate and provide clear documentation of analysis programs.
• Write Results and Methods sections of reports and manuscripts as needed.
• Consult with other staff on statistical and analysis issues.
• Lead the development of policies and procedures for the department and the statistics group.
• Mentor and train Statisticians and/or Senior Statisticians.
• Attend and contribute to project and department meetings.

• Bachelor’s degree with a minimum of 7 years of statistics experience or advanced degree with a minimum of 5 years of statistics experience.

• Master's degree or PhD in Biostatistics, Statistics, or equivalent.
• 7 years of post-graduate statistical experience.
• Experience in analysis of data from clinical studies and design of clinical trials.
• Strong applied statistical skills, including survival analysis, regression modeling, Bayesian methods, adaptive trial designs, and more.
• Advanced knowledge of statistical programming packages, including SAS, R, or others.
• Experience communicating complex statistical/machine learning results to both technical and non-technical audiences.
• High level of knowledge of clinical trial methods and execution.
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices.
• Participation in FDA regulatory meetings and experience with global regulatory submissions.
• Demonstrated ability to communicate technical content to non-statisticians.