job details
summary.
- Lausanne, Vaud
- Temporary
- specialismlife sciences
- contactMargot Ferraton
- reference number19053
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Responsabilities
- Contribute to clinical development plans, concept sheets, protocols, Clinical Study Reports, Briefing Books, ISS/ISE, submission data packages preparations, 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/review detailed timelines forecasting for biostatistics related deliverables; actively contribute to cost tracking related to the functional deliverables; ensure GCP compliance and act as the biostatistics representative for audits and inspections
- Effectively collaborate with Biostatistics, Statistical Programming and Data Management colleagues as well as with Pharmacokinetic experts for input and information exchange to facilitate best practices across all clinical studies/programs.
- Participate in CRO selection processes and input to process improvement and standardization in collaboration with cross functional colleagues. Assess new methodologies or technologies when applicable. Provide CRO oversight to achieve high quality deliverables within agreed timelines and budget.
- Strong statistical expertise.
Profile
- Master’s degree (or equivalent) or PhD in Statistics, Biostatistics or related discipline
- Strong SAS expertise
- Good knowledge of ICH and other relevant guidance documents (from FDA, EMA, …)
Responsabilities
- Contribute to clinical development plans, concept sheets, protocols, Clinical Study Reports, Briefing Books, ISS/ISE, submission data packages preparations, 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/review detailed timelines forecasting for biostatistics related deliverables; actively contribute to cost tracking related to the functional deliverables; ensure GCP compliance and act as the biostatistics representative for audits and inspections
- Effectively collaborate with Biostatistics, Statistical Programming and Data Management colleagues as well as with Pharmacokinetic experts for input and information exchange to facilitate best practices across all clinical studies/programs.
- Participate in CRO selection processes and input to process improvement and standardization in collaboration with cross functional colleagues. Assess new methodologies or technologies when applicable. Provide CRO oversight to achieve high quality deliverables within agreed timelines and budget.
- Strong statistical expertise.
Profile
- Master’s degree (or equivalent) or PhD in Statistics, Biostatistics or related discipline
- Strong SAS expertise
- Good knowledge of ICH and other relevant guidance documents (from FDA, EMA, …)
get in touch.
we are here to help you with your questions.
Margot Ferraton
- +41 58 201 54 40
- Geneva Professionals Health Care & Life Sciences
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