CMC Senior Statistician
GSK
Siena, Italy
4 gg fa

Job purpose : When it comes to developing the Vaccines of the future, we’re looking for real experts who are interested in working in the stimulating environment of an international healthcare company.

If you have strong ambition, solid technical skills and passion for innovation and global-working, and you want to make a difference to patients’ lives then YOU could be the future of GSK Vaccines business.

As a Senior Statistician, you’ll join a global team of statistics experts (Global Projects Statistics team)tobringallaspectsofnon-clinicalstatisticsinTechnicalResearch&Developmentduring product,processandanalyticaldevelopment,regulatoryapproval,technicaltransferand commercialization of new Vaccines.

You’ll be an essential and accountable partner of technical project teams, management and key stakeholders in theorganizationinprovidingstatisticalexpertise.

You’llapplyfit-for-purpose, advanced and state-of-the-art statistical principles in a wide variety of situations.

You’ll Influence internally and externally to adopt rigorous and sound statistical approaches which have large organizational, strategic and business impact.

Your responsibilities :

  • Youactasessentialpartnerforprojecttechnicalteams(e.g.TechnicalDevelopment Leader, functions representatives, ...) or other stakeholder groups and provide statistical expertiseinallaspectsofTechnicalResearch&Development(Product,Processand AnalyticalDevelopmentandcommercialisation)bringingtheaddedvalueofdata-driven decisions.
  • You ensure full integration of statistics across functions into everyday work as appropriate basedonacloseanddeeppartnershipwithscientists.
  • Youensureadvancedstatistical conceptsareroutinelybeingappliedduringthedevelopmentofproduct(e.g.stability modelling),process(e.

    g.modellingandsimulationofbiopharmaceuticalprocess)and analytical methods (e.g. bioassays development) to ensure competitive and state of the art quality and productivity.

  • YoutakefullownershipandaccountabilityofallstatisticalcontentinaQbDframework. Typicalapplicationsincludetheestablishmentofexperimentalstrategiesandthe evaluationofexperimentalresultsforprocess / analyticalmethoddevelopmentand validation, technical transfers, critical investigations etc.
  • You master a broad range of statistical sciences applications, such as linear model, DOE, samplesize,multivariateanalysis,modelling,simulation,machinelearning,.
  • with knowledge of statistical and programming software (e.g. SAS, R, JMP, Python, ...).
  • You upskill the organisation on the application of statistics by providing training.
  • You ensure high quality regulatory dossiers which set the benchmark in the industry and result in high regulatory acceptance.
  • Youmanageexternalandinternalcollaborationswithstatisticalthoughtleadersand statisticalgroupsinotherfunctionsanddivisions.
  • YouinfluenceGSKinternalpolicies, guidelinesandStandardOperatingProcedures(SOPs)toensureappropriatestatistical applicationandrepresenttheorganizationonkeyconferencesandadvocacygroupsin order to influence the external and regulatory environment.

  • You provide statistical expertise for all global development in compliance with current ICH / FDA, QbD guidelines and SOPs.
  • YoustayuptodatewithlatestdevelopmentsinthefieldofstatisticsandexploreCMC applications for our organization.
  • You support improvement of data collection and management to enable quick and reliable data analysis.
  • Why you?

    Basic Qualifications :

    We are looking for professionals with these required skills to achieve our goals :

  • University degree (Master / PhD) in Data Science, Statistics, Mathematics, or related field
  • Ideally >
  • 7 years relevant work experience in applying statistics within industry, preferably pharmaceutical environment

  • Fluent English required; second language desirable (e.g. Italian, French)
  • Preferred qualifications :

    If you have the following characteristics it would be a plus :

  • Experience of working in global and agile cultural teams
  • Experience in cross-functional teams
  • Ideally experience in Quality by Design as applied to biologics and vaccines
  • Ideally knowledge of vaccines industry, especially in the development, approval and commercialization of vaccine products
  • Continuous learning and entrepreneurial mindset to support implementation of GSK’s digital strategy
  • Strong communication, collaboration and influencing skills
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