Senior Statistician

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee all biostatistical tasks associated with clinical trials as the lead project statistician.

• Engage with project teams, clients, and vendors regarding statistical inquiries.

• Create and evaluate statistical sections of protocols, which includes calculating sample sizes.

• Design statistical analysis plans.

• Establish and document the structure of analysis databases (e.g., SAS analysis data set structures).

• Define requirements and specifications for SAS programming.

• Conduct SAS programming and validate programs.

• Review and ensure quality control of statistical outputs (tables, listings, figures, etc.).

• Execute statistical analyses and report findings.

• Provide consultation on experimental design, statistical methodologies, and approaches to evaluate the safety and efficacy of drug products.

• Collaborate with Data Management on statistical inquiries related to data issues, including coordinating data transfers from DM to Statistics.

• Engage in bid defense meetings and project kick-off meetings.

• Mentor statisticians and SAS programmers.

• Prepare and present at investigators' meetings.

• Address audit findings and recommendations, ensuring follow-up and resolution of audit issues.

⛳️ Requirements

• Master's degree in Statistics or a related field.

• Comprehensive knowledge and understanding of the statistical principles, concepts, methods, and standards utilized in clinical research.

• Capability to apply a variety of advanced statistical techniques to support clinical research studies and to analyze, interpret, and derive insights from complex statistical data.

• Proficiency in consulting with clinical investigators, interpreting research needs, and formulating statistical analysis strategies.

• Extensive knowledge and understanding of SAS programming.

• In-depth knowledge of the CDISC ADaM standard.

• Familiarity with relevant regulations and guidelines (e.g., FDA, EMA, ICH).

• Proficient in English.

🏝️ Benefits

• Employees have the option to work remotely.