Prin Statistician (Clinical) - Mounds View, MN 55112 (Hybrid/Remote)

About the role

We are seeking an experienced Principal Statistician (Clinical) to support the design, analysis, and execution of clinical research programs for innovative medical device products. This role is ideal for a seasoned biostatistician with expertise in clinical trial design, statistical methodology, SAS programming, and regulatory submissions. As a key member of the clinical research team, you will provide statistical leadership throughout the product development lifecycle from study design and protocol development to regulatory submissions and publication of clinical results. You will collaborate closely with clinicians, statistical programmers, regulatory affairs, and cross-functional stakeholders to ensure high-quality statistical analyses that support product safety, efficacy, and regulatory approval.

Key Responsibilities

• Design, plan, and lead the biostatistical strategy for clinical research and product development programs.
• Develop statistical methodologies to support clinical studies throughout the product lifecycle.
• Prepare statistical sections of clinical protocols, ensuring compliance with regulatory guidelines and clinical trial standards.
• Perform statistical analyses using SAS, R, or other statistical programming software.
• Develop, review, and execute Statistical Analysis Plans (SAPs).
• Calculate sample size, statistical power, and study design assumptions for clinical trials.
• Analyze and interpret clinical study data, presenting results through tables, figures, and statistical reports.
• Validate statistical programming and maintain clear, compliant analysis documentation.
• Collaborate with clinicians, statistical programmers, data management, and regulatory teams throughout study execution.
• Identify risks to study validity and recommend appropriate mitigation strategies.
• Support FDA and global regulatory submissions by providing statistical expertise and responding to regulatory inquiries.
• Prepare Results and Methods sections for clinical reports, publications, and scientific manuscripts.
• Contribute to departmental standards, statistical policies, and best practices.
• Mentor junior statisticians and provide technical leadership across clinical research projects.
• Participate in cross-functional project meetings and provide statistical consultation to internal stakeholders.

Required Qualifications

• Master's degree or higher in Biostatistics, Statistics, or a related quantitative discipline (minimum education preferred by hiring manager).
• Bachelor's degree with 7+ years of relevant statistical or biostatistical experience or an advanced degree with 5+ years of relevant experience.
• Minimum 5 years of experience supporting clinical research, biostatistics, or clinical data analysis.
• Strong expertise in statistical analysis methodologies and clinical trial design.
• Advanced experience with SAS programming and statistical analysis.
• Experience developing Statistical Analysis Plans (SAPs) and interpreting clinical trial data.
• Strong understanding of clinical research methodology and statistical inference.
• Excellent written and verbal communication skills with the ability to explain complex statistical concepts to technical and non-technical audiences.

Preferred Qualifications

• PhD in Biostatistics, Statistics, or a related quantitative field.
• 7+ years of post-graduate statistical experience.
• Experience analyzing clinical trial data for medical devices, pharmaceuticals, or biologics.
• Expertise in: Survival analysis, Regression modeling, Bayesian statistics, Adaptive clinical trial designs, Group sequential methods, Longitudinal and mixed-effects models, Interim analyses, Missing data methodologies, Multiple comparison procedures.
• Advanced proficiency with SAS, R, or other statistical programming platforms.
• Experience supporting FDA or global regulatory submissions.
• Working knowledge of Good Clinical Practice (GCP), ISO, MDD/MDR, and medical device regulatory requirements.
• Experience participating in FDA advisory meetings or regulatory panel presentations.
• Strong publication record, scientific presentations, or conference experience.
• Experience writing clinical study reports, statistical reports, and regulatory documentation.

Top Skills

• Statistical Analysis
• Clinical Research
• SAS Programming
• Clinical Trial Design
• Biostatistics
• Statistical Analysis Plans (SAP)
• Regulatory Submissions
• Clinical Data Analysis
• FDA & GCP Compliance
• R Programming
• Sample Size & Power Calculations
• Medical Device Clinical Research