This position is no longer open for applications

Research & Development – Statistician
Pharma industry
Area Utrecht
20 hours

Function
We are seeking a highly skilled and experienced Statistician to join our team as a contractor, who will be responsible for providing statistical support for clinical trials. The contractor statistician will be responsible for designing clinical trial protocols, writing statistical analysis plans, conducting statistical analyses of clinical trial data, and generating reports to support the development of new products.

Your responsibilities

• Support and help in development of clinical trial protocols that meet regulatory requirements, scientific objectives, and ethical principles.
• Develop statistical analysis plans, including sample size calculations, randomization procedures, and statistical methods for efficacy and safety analyses.
• Conduct statistical analyses of clinical trial data using appropriate software packages such as SAS and R.
• Collaborate with study teams and provide statistical guidance on study design, data collection, analysis and interpretation of clinical trials.
• Prepare and present statistical plans and study reports.
• Provide statistical expertise for the preparation of regulatory submissions.
• Ensure the accuracy, validity, and completeness of data analyses.
• Stay up to date with the latest statistical methods and regulatory requirements for clinical trials.

Requirements

• A master's degree in Statistics, Biostatistics, or related fields (PhD. is preferred) with at least 5 years of experience in (clinical trial) design and analysis.
• Strong and broad knowledge of statistical methods for clinical trials, including experience with survival analysis, mixed models, and non-parametric methods.
• Experience with software packages such as SAS and R.
• Knowledge of regulatory requirements for clinical trials, including FDA, EMA, and ICH guidelines.
• Excellent communication and interpersonal skills, with the ability to work effectively in a team-oriented environment.
• Strong problem-solving skills and attention to detail.
• This is a contract position that requires the ability to work in a hybrid way and, on a project-by-project basis. Regular presence in the Utrecht office is required. The contractor statistician must be able to work independently and manage multiple projects simultaneously while meeting agreed timelines.