Statistician - Department of Orthopaedic Surgery and Sports Medicine

University of Florida•Gainesville, FL

10d

About The Position

The Statistician applies rigorous statistical methodologies to design, analyze, and interpret clinical research studies. The role supports investigators in planning trials, monitoring data integrity, and creating reports that meet regulatory standards. The role blends technical expertise with collaboration across multidisciplinary teams to ensure data integrity, accessibility, and security.

Requirements

A Bachelor’s Degree in data science, statistics, bioinformatics, analytics, or similar field and two years of experience; Master’s Degree in data science, statistics, bioinformatics, analytics, or similar field.

Nice To Haves

Proficiency in statistical software (e.g., SAS, R, SPSS) and experience with clinical trial data systems.
Solid understanding of regulatory requirements (ICH GCP, FDA 21 CFR Part 11, EMA guidelines).
Strong analytical skills and a meticulous approach to data handling and documentation.
Experience with adaptive designs, Bayesian methods, or advanced longitudinal modeling.
Familiarity with data visualization tools and effective communication of complex results to non‑statistical audiences.
Ability to work collaboratively in multidisciplinary teams and manage multiple projects concurrently.
Critical‑thinking mindset with a proactive approach to problem solving.

Responsibilities

Design study protocols, randomization schemes, sample size calculations, and interim analysis plans.
Develop and validate statistical analysis plans (SAPs) that align with regulatory guidelines (e.g., FDA, EMA) and internal standards.
Conduct statistical analyses on clinical trial data, ensuring accuracy, reproducibility, and compliance with pre‑specified methods.
Collaborate with biostatisticians, data managers, and clinical teams to address data‑quality issues and troubleshoot analyses.
Prepare and review statistical sections of study reports, manuscripts, and regulatory submissions.
Participate in protocol development meetings, providing statistical input on feasibility, outcomes, and endpoints.
Mentor junior staff and trainees in statistical concepts and best practices.
Develop and supervise data collection, entry, and validation protocols for clinical and research studies.
Maintain and optimize electronic data capture (EDC) platforms (e.g., REDCap, EPIC, custom solutions).
Implement data quality assurance processes, including audits, error tracking, and query resolution.
Ensure compliance with institutional, federal, and state regulations (IRB, HIPAA, GDPR, etc.).
Produce routine data summaries, statistical reports, and dashboards for investigators, clinicians, and administrators.
Occasional travel to study sites, conferences, or regulatory meetings may be required.