Statistical Modeler & Simualtion Expert
Argenx
Gent
1 dag geleden

Key Accountabilities / Responsibilities :

  • Identify opportunities to implement innovative statistical methods to clinical trial design and analysis in translational medicine
  • Plan, run, and summarize simulation studies to evaluate the operating characteristics of alternative designs and methods.
  • Participate in the implementation of the selected approaches by engaging in protocol and SAP write-up
  • Modeling and Simulation efforts to provide answers to complex statistical problems
  • Gain insight in the specific disease area and the competitive landscape through focused literature search and summarizing of public available data
  • Stay current with relevant statistical literature and guidance’s
  • Help to determine the R / SAS environment and infrastructure
  • Implement best practices in terms of application of statistical methods.
  • Engage with external consultants and qualified CROs that provide support to the development and implementation of statistical methodology.
  • Desired skills and Experience :

  • PhD in (bio)statistics with a minimum of 5 years of working experience in model-informed drug development.
  • A pioneer who likes working in a rapidly evolving environment.
  • Experience with statistical modeling and trial simulations using R, SAS and other relevant software such as ADDPLAN and / or EAST, and a good working knowledge about Bayesian methodology and adaptive designs.
  • Demonstrated track record of specialization in certain statistical domains that have relevance to drug development.
  • Knowledgeable about clinical pharmacology and able to acquire in-depth knowledge about the disease area.
  • Keen learner, a strategic thinker and knowledgeable about the various aspects of clinical development and regulatory requirements.
  • Excellent written and oral communication skills and the ability to work in a multi-disciplinary environment.
  • Team player whith excellent interpersonal skills.
  • Offer :

  • A competitive salary package with benefits;
  • A work environment in a human-sized, dynamic, rapidly growing biotech company
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