JobdescriptionFor our client, specialized in pharmaceutical industry and based in the Vaud canton, we're looking for a Senior Manager Biostatistics (100%)
Responsabilities
- 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.
- Interact proactively and solution orientated with other clinical and non-clinical functions
Profile
- Master's degree (or equivalent) or PhD in Statistics, Biostatistics or related discipline.
- 8 years min. of related industry experience within the functional area.
- Strong SAS expertise or R
- Good knowledge of ICH and other relevant guidance documents (from FDA, EMA, ...)
- Familiar for Estimand concept
- Highly motivated and enjoys working in a fast-paced environment.
- English speaker (fluent). French is a plus
Margot Ferraton