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水平: Director
工作类型: Full-time
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工作内容
Hobson Prior are currently seeking for a Head of Biometrics and Statistical Programming to join a fantastic pharmaceutical organisation on a permanent basis located in Wedel. Our client is focused on producing various drugs and medical products for the diagnosis and treatments of various therapeutic areas.Please note that to be considered for this role you must have the right to work in this location.Key Responsibilities- For this role, you will guide the team of biometricians and statistical programmers.
- You will serve as a representative of statistics at regulatory authorities, for example: EMA, FDA, PMDA, etc.
- Evolve and execute internal procedures and quality standards.
- Share technical knowledge as part of the cross-functional project teams from science and marketing.
- Manage statistical-methodical conception of international clinical development programs.
- Contribute to the statistical planning, review and documenting of clinical studies of phases I to III.
- Any other assigned duties.
- People focused leadership experience.
- An independent individual with a structured and result focused way of working.
- A confident individual who enjoys as well as works well in a team.
- Educated to a degree level in a statistics, medical biometrics or mathematics organisation.
- At least 5 years of experience in a clinical development role within a pharmaceutical organisation.
- Know-how of regulatory needs for statistics and statistical programming.
- Familiarity with CDISC data standards, statistical programming with SAS & R as well as any other popular statistical speciality software packages.
- In-depth knowledge of phase II and III statistical tactics, and early clinical research such as dose-response modelling, popPK models, pharmacometric modelling, BV/BE studies, and Bayesian methods.
- Fluency in both the German and English languages.
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最后期限: 06-12-2024
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