An amazing opportunity has arisen in Frankfurt is serve as Lead Biostatistician. You will responsible for driving input, providing expert guidance on study design and interpretation of finding and reporting of results. This is a chance to establish your statistical career at a leading pharmaceutical firm.
- Acts as the lead biostatistician for one or more clinical studies within a clinical program or across multiple clinical programs.
- Gives input into the study design, efficacy and safety parameters and the planned statistical analyses.
- Participates in protocol development if this is not delegated to an external partner biostatistician.
- Reviews and approves the protocol prepared by the external partner biostatistician.
- Supports or overseas external partner biostatistical support for all statistical operational aspects of the clinical trial, covering trial set up, trial delivery and the readout of results.
- This includes input into randomisation specifications, statistical analysis plans, interim analyses, safety reviews and final analyses.
- Communicates and coordinates all statistical activities with external partner biostatisticians. Ensuring the implementation of global, program and SSI standards by all biostatisticians contributing to the project.
- Provides input on interpretation of results by attending and presenting at the Results Interpretation Meeting (RIM). Reviews and inputs into the clinical study report.
- Assists the Project Lead Statistician 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
- PhD with 5+ years of experience
- Master's degree with 7+ years of experience
- 5-7 years of biostatistics experience within the Biotechnology and/or Pharmaceutical Industry (including clinical research organizations) or relevant academic role with proven successful track record in pharmaceutical development.
- Good knowledge of SAS and/or R programming.
- Excellent written and verbal communication skills in English.
- Contributes to an environment of mutual confidence and co-operation among the team and with the research and development partners.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.