Hobson Prior are currently working with a world-wide aesthetics and neurotoxin organisation who are seeking a Biostatistical Lead to join them on a permanent basis in Frankfurt.
Provide statistical contribution to clinical development programs and clinical trials/investigations, including Clinical Development Plans, CTDs, etc.
Outline statistical aspects of a clinical trial in the Clinical Trial Protocol including writing the Statistical Analysis Section.
Evaluate and participate in Clinical Trial Protocols, Clinical Study Reports, etc.
Deliver input to data collection instruments, data management and data validation processes definition of risk-based monitoring procedures and other aspects of data collection and validation.
Stipulate, organise or conduct and quality control the statistical analysis activities for individual studies and integrated analyses (e.g. ISE, ISS).
Outline randomization process details; initiate, direct and conduct unblinding process.
Manage any statistical activities outsourced to CRO.
Direct and discuss all statistical aspects in communication with regulatory bodies.
Examine and provide input to scientific publications and present study results.
Work closely with other R&D functions and Medical Affairs including consultation on statistical topics (e.g. in preclinical projects, publications, etc.)
Enhance and update biostatistics processes to reflect possible changes in regulatory and organisational requirements
Business fluent in English (written & verbal).
Prior experience with ICH, GCP, FDA guidelines.
Strategic and analytical thinking.
Willing to work as a team as well as autonomously.
High sense of responsibility and quality awareness.
Analytical and highly structured way of working.
Educated to a degree level in Statistics, Mathematics, Natural Sciences or similar.
At least 5 years' experience in Biostatistics.
Experience with EDC systems and SAS
Experience with CDISC data standards would be advantageous.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
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