Principal Biostatistician

A large pharmaceutical organisation, is looking for a talented Principal Biostatisitician to join their team in Germany. This organisation is dedicated to putting patients at the heart of their journey and bringing about effective change in medicine.

Job Responsibilities

• Provide input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts and manuscripts to ensure that statistical elements are in line with leading edge knowledge and the overall product strategy
• Define and drive statistical strategy across programs ensuring acceptable statistical methodology to competent authorities and scientific community.
• Inform health economic analysis within HTA Lead the development of the statistical analysis plan for clinical trials
• Provide specifications and directions to the statistical programmers in establishing standards for clinical conduct and data collection, management and/or reporting of data
• Manage and supervise CROs regarding statistical activities to ensure timely delivery of Statistical deliverables and provide guidelines and standards to CROs to ensure quality of deliverables
• Identify, evaluate, and promote the use of innovative statistical methodology within and outside the organisation through scientific collaborations, publications in scientific peer reviewed journals, presentations
• Contribute to interactions with external review boards / ethics committees, external consultants and key opinion leaders

Skills and Requirements

• Master's or doctoral degree in Biostatistics, Statistics, Epidemiology or Mathematics
• Ideally a minimum of five to eight years experience in Pharma, Biotech, CRO or similar sector with previous experience in applying statistical methods in safety-related aspects of biomedical research Expertise in SAS and/or R to perform statistical analysis
• Experience applying Bayesian models in biomedical research
• Familiarity with complex statistical methods that apply to Phase I-IV clinical trials, including adaptive designs
• Ideally more than two years of experience as an HTA statistician and in analysing safety data in clinical trials
• Experience of safety signal detection with appropriate statistical tools, expertise in epidemiologic methods and meta-analyses

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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