Director of Biostatistics
Job type: Permanent
Location: Frankfurt, Germany
A leading Immuno-Oncology Pharmaceutical company is seeking to appoint a new Director of Biostatistics to lead, mentor and evaluate performance of the Biostatistics department. The selected candidate will provide statistical input into other disciplines' activities and participate in interdepartmental processes as well as providing technical solutions and advice to staff and clients on statistical processes.
Key responsibilities include:
- Independently lead the development and execution of statistical aspects for various complex clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications.
- Collaboratively develop strategic plans, make recommendations on fit-for-purpose data and analytics solutions,
- Create high quality analyses, and ensure appropriate interpretation of results
- Able to offer statistical advice, sample size estimates and involved in the participation in the creation of study protocols.
- Demonstrate knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments and application within development teams
- Assure effective integration of Biometrics work with all other functions and cultivates the application of statistical principles across company portfolios
Key requirements include:
- PhD or MSc in Statistics, Biostatistics or related field of study.
- Minimum of 10 years' experience in pharmaceutical and/or biotech industry
- At least 5 years' experience managing other biostatisticians, real-world evidence analysts or CROs.
- Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research.
- Experience planning and preparing for regulatory meetings.
- Expertise in statistical / clinical trials methodology as it relates to clinical development.
- Expert knowledge of relevant regulations and guidelines (e.g. ICH, EMA and FDA).
- Ability to communicate and present statistical findings to non-statisticians, and determine statistical analysis strategies.
- Expert in SAS
- Exceptional organisational and problem solving skills.
- Fluent in English language (both verbal and written)
To find out more about this fantastic opportunity please contact Matt Murray on +44(0)2037588975.