Senior Statistician

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

📋 Description

• Oversee all biostatistical functions related to clinical trials as the lead project statistician

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

• Create and evaluate statistical sections of protocols, including sample size estimations

• Formulate statistical analysis plans

• Design and document analysis database frameworks (e.g., SAS analysis data set structures)

• Establish SAS program specifications and requirements

• Conduct SAS programming and validation of 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 strategies for evaluating the safety and efficacy of pharmaceutical products

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

• Take part in bid defense and kick-off meetings

• Mentor statisticians and SAS programmers

• Prepare and present findings at investigators' meetings

• Respond to audit findings/recommendations, and follow up on the resolution of audit issues

⛳️ Requirements

• Master's degree in Statistics or a related field

• In-depth knowledge and comprehension of statistical principles, concepts, methods, and standards utilized in clinical research

• Proficient in applying various advanced statistical techniques to support clinical research studies and capable of analyzing, interpreting, and deriving conclusions from complex statistical data

• Competent in consulting with clinical investigators, interpreting research needs, and determining appropriate statistical analysis approaches

• Extensive knowledge and understanding of SAS programming

• Proficient 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