An international pharmaceutical company is advertising a vacancy for a Principal Biostatistician, based in Berlin. This position offers an exciting opportunity to work with an innovative company whose medicines are used by millions of patients worldwide.
- Ensure that scientific questions for research objectives are defined clearly and that data collection, statistical methods and analyses are optimally designed to provide statistical evidence to answer those questions in alignment with project objectives.
- Provide insight on the risk associated to a decision.
- Be deeply involved in the continuous development of the statistical expertise and improvement of the quality and compliance.
- Establish/implement solutions for standardisation within the team and at business.
- Acts as the lead biostatistician for one or more clinical studies within a clinical program or across multiple clinical programs.
- Supports or oversees external partner for all statistical operational aspects of the clinical trial, covering trial set up, trial delivery and the readout of results.
- Communicates and coordinates all statistical activities with external partner biostatisticians.
- Provides input on interpretation of results by attending and presenting at the Results Interpretation Meeting (RIM).
- Assists the biostatistician lead for a program of studies with the statistical deliverables for regulatory submissions and the lifecycle of a development compound.
- Principal Biostatistician can serve as a biostatistician lead for a program of studies, as agreed to by their line manager.
Skills and Requirements
- 5+ (with PhD) to 7+ (with Master's degree) years in biostatistics within the Biotechnology and/or Pharmaceutical Industry or relevant academic role with proven successful track record in pharmaceutical development.
- Excellence in a variety of relevant statistical methodologies, including Bayesian approaches.
- Good knowledge of SAS and/or R programming.
- Excellent knowledge in visualization and simulation techniques.
- Able to work under pressure and without supervision.
- Able to drive and influence teams to ensure evidence-based decisions are made
- Able to provide training of statistical topics to biostatisticians and to explain statistics topics in a non-technical manner to non-statisticians.
A full job description is available on request.
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