Job Reference: J5631391
Updated On: 13/05/2019
Status: Open to Applications
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Director of Biostatistics
Role OverviewWe are currently looking for a Director of Biostatistics to join a leading biotechnology company based in the Stevenage, Hertfordshire area. As the Director of Biostatistics you will be responsible for providing leadership and guidance on biostatistic projects across pre clinical trial and clinical trial data
Key Duties and ResponsibilitiesYour duties as the Director of Biostatistics will be varied however the key duties and responsibilities are as follows:
1. You will lead and guide the business proving insights in biostatistics data for pre clinical and clinical trial projects
2. The Director of Biostatistics will participate in new drug development programmes and give expert advice for statistics, as well as providing statistical leadership in the design of clinical development plans
3. You will be accountable for statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity.
4. As the Director of Biostatistics as well as being responsible for the overall strategy for statistics you will also have line management responsibility for data management and statistics team members
To be successful in your application to this exciting opportunity as the Director of Biostatistics we are looking to identify the following on your profile and past history:
1. Ideally you will have a PHD or Master in Statistics or Biostatistics and have worked in a clinical trial or pre clinical trial environment
2. You will need to have advanced knowledge of statistical methods in clinical study designs, clinical data analyses (from Phase I through Phase IV), including statistical procedures in analysis software (e.g., SAS).
3. You will need to be able to demonstrate extensive hands-on experience with statistical analysis plans, study protocols, clinical study reports, integrated summary of safety and efficacy reports, Investigator Brochures, and annual reports (or periodic safety update reports).
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