Senior Manager Biostatistics (m/f/d)
5 months extendable for a long term absence cover
With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.
In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.
- Contribute to the development plans, concept sheets, protocols, Clinical Study Reports, Briefing Books, ISS/ISE, submission package, interactions with Health Authorities. Lead or responsible for the oversight of Statistical Analyses Plans and other statistical deliverables.
- For projects under direct responsibility:
- provide input for detailed timelines forecasting for biostatistics related deliverables.
- Actively contribute to cost tracking related to the functional deliverables.
- biostatistics representative for audits and inspections.
- Manage and troubleshoot operational challenges, GCP compliance, and standardization in collaboration with cross functional colleagues according to the level of expertise.
- Effectively collaborate with Biostatistics, Programming and Data Management colleagues as well as with Pharmacometrician for input and information exchange to facilitate best practices across all studies/programs.
- Participate in CRO selection process and provide CRO oversight to achieve high quality deliverables within agreed timelines and budget.
- Provide input to process improvement: assess new methodologies or technologies when applicable; contribute to the development, review and update of BDM SOPs as company/situations evolve.
- Collaborate effectively with cross-functional teams and external partners.
- Maintain strong and broad based statistical expertise.
- Master’s degree (or equivalent) or PhD in Statistics, Biostatistics or related discipline.
- 10+ years of related industry experience within the functional area.
- Strong SAS expertise.
- Ability to think beyond the home function, identifying connections between different areas of the organization to see the broader perspective.
- Good knowledge of ICH and other relevant guidance documents (from FDA, EMA, …).
- Strong communication skills; verbal, written, and presentation.
- Highly motivated and enjoys working in a fast-paced environment.
- Strong organizational skills and the ability to prioritize and multi-task.
- Positive, flexible self-starter who thrives under pressure.