Responsibilities:

• Planning, managing and execution of statistical programming deliverables in clinical trial and non-trial activities in the project
• Providing input to authority required documents for the trial and non-trial activities
• Ensuring that clinical trial and non-trial tasks are aligned with the project specifications
• Responsibitly for continuous development of own skills and to contribute to the development of Biostatistics
• Providing programming input to the setup of the trial, including but not limited to the CRF, Trial Validation Plan and Data Flow Plan
• Ensuring that mock TFLs are created and reviewed by stakeholders
• Making AdaM programming according to industry standard and NN specifications
• Ensuring that programming, also by co-workers and functional suppliers, is done according to specifications
• Ensuring that the inspection readiness documentation is updated at all time during the trial life cycle
  
  

Required skills and experience:

• +3 years of statistical programming, and preferably 1 year within the pharmaceutical industry or equivalent knowledge through relevant experience
• Extensive experience with programming in e.g. SAS or R
• Experience with reporting clinical trials, including statistical data handling, analysis and reporting
• Experience with review and documentation of programs
• Good knowledge of drug development
• Experience with clinical database technologies, data models and advanced programming
• Experience with collaboration across professional and regional borders
• Regular experience with communication and presentations
• In-depth knowledge of computer systems and IT
• Good knowledge of GxP and guidelines within drug development

To apply for this role visit: Senior Statistical Programmer II vacancy role