• Expert Biostatistician Siena
  • GSK in Siena, Province of Siena, Italy
  • jobs
  • 1 month ago

jobs description

Site Name:
Belgium-Wavre, Amsterdam, GSK House, Italy - Siena, Netherlands - Amsterdam

Posted Date:

We are looking for an Expert Biostatistician to expand our team and provide statistical expertise to support the different study designs.
Key Responsibilities
• You use stat methodology to establish study strategy modelling of different scenarios, set up power monitoring, set up mitigation plan to minimize risk of stat failure)
• You provide input to protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis)
• You provide input to study set up (CRF review, randomization, DMP plan including specification for subset, important protocol deviation)
• You develop SAP/AAR (involving sensitivity analysis to support robustness of result) and coordinate review
• You review the TFL, to coordinate review with the stat analyst, to approve the TFL
• You do the QC of the statistical analysis methodology
• You validate study specific dataset & analysis pgm... specification
• You approve deviation from TFL format
• You propose SAR conclusion
• You prepare answer to study specific stat question (e.g. inspection, RA question)
• You provide stat support to an independent analysis center
• You provide consultancy on stat matter for other statisticians
• Why You?_


- at least 5-year experience of pharmaceutical industry
• Has been previously responsible for studies with different designs (dose range, superiority/non inferiority, futility rule,..)
• Experience in SAS software and sample size computation for standard designs
• Ability to work in multidisciplinary team (e.g. give guidance to nonstat, provide feedback, engage), some being remotely located
• Good oral and written communication in English including ability to explain difficult issues and situations clearly and ensures meaning is understood

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
• *Important notice to Employment businesses/ Agencies
Siena Province of Siena Italy


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