Prin Statistician

About the Role

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, pharmaceutical, and/or biological products. Uses sound statistical methodology to conduct studies relating to the product life cycle.

Responsibilities

• Prepares the statistical component of protocols for development-phase projects, ensuring alignment with 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 for statistical inference, and authors the statistical component of study reports.
• Provides specifications and directions to clinicians and statistical programmers.
• Supports regulatory review and approval of experimental therapies, including FDA and global submissions.
• Partners in trial design and establishes standards for clinical conduct, data collection, management, and reporting.
• Applies statistical knowledge to clinical study design, including sample size and power calculations, and design assumptions from published literature.
• Identifies potential threats to study credibility and validity, collaborating with the study team to mitigate risks.
• Authors the statistical analysis plan for studies.
• Performs statistical analysis using programming software (e.g., SAS, R).
• Leads responses to regulatory questions from agencies like the FDA, including negotiations on study design and interpretation.
• Validates and documents analysis programs with clear, reproducible methods.
• Writes Results and Methods sections of reports and manuscripts.
• Consults with non-clinical staff on statistical and analysis issues.
• Leads the development of departmental policies and procedures for the statistics group.
• Mentors and trains Statisticians and/or Senior Statisticians.
• Attends and contributes to project and department meetings.

Requirements

• Bachelor’s degree with a minimum of 7 years of statistics (e.g., biostatistics, data analysis) experience, or advanced degree with a minimum of 5 years of relevant experience.

Qualifications

• Master's degree or PhD in Biostatistics, Statistics, or equivalent (preferred).
• 7+ years of post-graduate statistical experience.
• Experience analyzing data from clinical studies and designing clinical trials.
• Strong applied statistical skills, including survival analysis, regression modeling, Bayesian methods, adaptive trial designs, group sequential methods, longitudinal analysis (mixed models), interim analysis, missing data strategies, and multiple testing strategies.
• Advanced knowledge of statistical programming packages (e.g., SAS, R).
• Experience communicating complex statistical or machine learning results to technical and non-technical audiences through publications, conferences, presentations, or seminars.
• High-level knowledge of clinical trial methods and execution.
• Experience with Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR).
• Prior experience with FDA and/or global regulatory submissions.
• Participation in FDA regulatory meetings, including panel preparation and presentation.
• Experience writing or updating clinical reports/documents.
• Demonstrated ability to communicate technical content to non-statisticians (written and verbal).

Role Differentiators

• Autonomy: Recognized expert managing large projects or processes with considerable latitude in determining deliverables and limited oversight. Coaches and delegates work to lower-level specialists.
• Organizational Impact: Contributes to defining direction for new products, processes, or standards with significant impact on work group results. May manage projects spanning beyond the immediate job area.
• Innovation and Complexity: Addresses difficult, moderately complex, and undefined problems requiring detailed analysis. Develops and implements solutions independently to enhance performance.
• Communication and Influence: Serves as a primary organizational contact for projects, communicating with internal/external stakeholders and influencing decision-making.
• Leadership: Provides guidance, coaching, and training to other employees. Manages major or moderately complex projects, including delegation and review of work products.

Pay

$60–$75 per hour, based on experience.