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Senior Manager Biostatistics.

détails du poste

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détails du poste
For 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
For 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

informations de contact.

nous sommes à ta disposition pour toute question.

MF

Margot Ferraton

Merci de t'être abonné à tes alertes emploi personnalisées.