Principal Statistician Early Phase (m/f)
Your tasks and responsibilities
- As a specialist in areas of statistical methodology relevant for early clinical development in specific therapeutic areas you build and lead high performing teams of statisticians and representatives from other functions as project lead.
- You ensure the use of appropriate and efficient statistical analysis methods during development, submission and/or life-cycle management of Bayer products according to applicable global and regional standards, procedures and regulatory guidelines.
- Take the statistical lead for a specific therapeutic area, assuming the role of clinical sciences statistician for multiple early clinical development projects and ensure appropriate development of this area within the department.
- You provide statistical and methodological consultation on special statistical methodology or on complex statistical, scientific and regulatory issues and mentor other statisticians and/or statistical analysts.
- You facilitate the overall organization and coordination of statistical activities on the level of the therapeutic area in addition to the projects for which you are responsible, also ensure appropriate prioritization within RCSS.
- You influence decision making processes during early drug development by use of appropriate statistical methodology (e.g. simulations, meta-analyses or modeling approaches).
- You keep abreast of regulatory and methodological issues, anticipate new needs in the area of responsibility and ensure development of innovative solutions.
- You drive development and implementation of innovative statistical methodology.
- You coordinate work with academic expects on themes related to the field of responsibility.
- You drive the development and implementation of project, therapeutic area, and global standards.
- You represent the function with respect to statistical aspects of early clinical development programs and products to internal and external stakeholders. These include regulatory agencies, collaborations/business partners, KOLs, etc.
Who you are
- PhD or MSc in Biostatistics, Statistics or Mathematics, or related field.
- Long-term experience as a statistician with significant time spend in pharma, biotech or similar sector
- Excellent knowledge of statistical programming languages (especially SAS and R).
- High level of expertise in multiple fields relevant for early clinical development including knowledge of Bayesian statistics or commitment to quickly acquire this expertise.
- Thorough knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents and regulations
- Demonstrated leadership skills in leading teams of statisticians and/or representatives from other functions
- Well-developed interpersonal, leadership and communication skills
- Ability to work independently as well as collaboratively, as required
- High affinity to internal and external collaboration, including commitment towards external visibility
- Fluent English skills
Bayer begrüßt Bewerbungen aller Menschen ungeachtet von ethnischer Herkunft, nationaler Herkunft, Geschlecht, Alter, körperlichen Merkmalen, sozialer Herkunft, Behinderung, Mitgliedschaft in einer Gewerkschaft, Religion, Familienstand, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität oder einem anderen sachfremden Kriterium nach geltendem Recht. Wir bekennen uns zu dem Grundsatz, alle Bewerberinnen und Bewerber fair zu behandeln und Benachteiligungen zu vermeiden.
Reference Code: 19173