Senior Biostatistician - Frankfurt
- Experience Level
- Experienced (non-manager)
Senior Biostatistician – Frankfurt, DE
Up to €95,000 (Salary D.O.E)
Experience: 3+ Years Required
Josh Zarembski is pleased to offer a fantastic opportunity to an experienced Biostatistician, with a leading Pharmaceutical organisation focused in the global market areas of Aesthetics &Therapeutics.
The innovative spirit of this company and the commitment to their staff make them an ideal organisation to take the next steps in your career. They have a highly attractive portfolio, a strong strategic focus, and a dynamic team which is leading to long-term growth and success.
This position can mainly be worked remotely with 1 day a week office based in Frankfurt to maintain social interaction of the team. Teamed with a strong compensation package, you will have the option of flexible working hours, personal & professional development plans.
- You provide statistical input to clinical development programs and clinical trials / investigations, including Clinical Development Plans, CTDs, etc.
- You define statistical aspects of a clinical trial in the Clinical Trial Protocol including writing the Statistical Analysis Section
- You review and provide input to Clinical Trial Protocols, Clinical Study Reports, etc.
- You deliver input to data collection instruments (e.g. CRF, diary), data management and data validation processes (e.g. data validation checks), definiton of risk-based monitoring procedures (e.g. signal detection process) and other aspects of data collection and validation
- You specify, coordinate or conduct and quality control the statistical analysis activities for individual studies and integrated analyses (e.g. ISE, ISS).
- You define randomization process details; initiate, coordinate and conduct unblinding process
- You oversee statistical activities outsourced to CRO
- You coordinate and discuss all statistical aspects in interaction with regulatory bodies such as Scientific Advice Meetings
- You review and provide input to scientific publications and present study results
- You interact with other R&D functions and Medical Affairs including consultation on statistical topics (e.g. in preclinical projects, publications, etc.)
- You optimize and update biostatistics processes to reflect possible changes in regulatory and organizational requirements
- Graduate studies in Statistics, Mathematics, Natural Sciences or similar
- At least 3 years experience in Biostatistics
- Business fluent in English (written and spoken)
- Familiarity with ICH, GCP, FDA guidelines
- Experience with EDC systems and SAS, ideally experience with CDISC data standards
- Strategic and analytical thinking
- Excellent communicating and team player skills
- High sense of responsibility and quality awarenessess
- Analytical and highly structured way of working
- AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
- If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.alsolutions.co.uk or reach out to us via:
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