An excellent job opportunity has arisen for a Director of Biostatistics to join a Swiss pharmaceutical company. This organisation specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition.
- Provide statistical input 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, review of SDTM/ADaMpackages, and other statistical deliverables.
- Pro-actively contribute to the strategic development of biosimilars
- Manage and troubleshoot operational challenges, GCP compliance, and standardization in collaboration with cross functional colleagues.
- Effectively collaborate with all Biostatistics and Data Management colleagues for input and information exchange to facilitate best practices across all studies/programs.
- Participate actively in CRO selection process.
- Collaborate effectively with cross-functional management teams and external partners. Interact proactively and solution orientated with other clinical and non-clinical functions
- Develop, review, update, and add SOPs as company/situations evolve when applicable.
Skills and Requirements
- Master's degree (or equivalent) or PhD in Statistics, Biostatistics or related discipline.
- 12+ 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.
- Excellent knowledge of ICH and other relevant guidance documents (from FDA, EMA, …)
- Strong organizational skills and the ability to prioritize and multi-task.
- Excellent judgment and problem-solving skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Tom Magenis at 0203 854 1050 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.