Senior Pharmacometrician
F. Hoffmann-La Roche Ltd
Basel Headquarter,Basel-City,Switzerland,
vor 4 Tg.

Accountable for the scientific and technical quality of the pharmacometric support provided in a timely manner for clinical development projects in Oncology.

The senior pharmacometrician will integrate and translate the scientific knowledge from clinical studies into mathematical / statistical models, in order to support optimal decision making in drug development from early to late phase of clinical development including filing activities.

S / he will plan, develop and execute modelling and simulation (M&S) activities in accordance with the overall Clinical Pharmacology strategy defined together with the Clinical Pharmacologist and the Disease Modeler.

Major Responsibilities and Accountabilities

  • Develops and maintains timely, scientifically sound, innovative and business-oriented M&S strategy for the projects in accordance with the Clinical Pharmacology strategy defined together with the Clinical Pharmacologist and the Disease Modeler
  • Develops and executes appropriate pharmacokinetic and pharmacodynamic (PK / PD) models for the project
  • Conducts simulations to illustrate the impact of development decisions such as dosage regimen selection, subgroup selection, and other trial design features
  • Clearly communicates the analyses outcomes for internal decision making or official project-related documents or peer-reviewed journals
  • Interacts with key stakeholders to ensure efficient and appropriate M&S strategy and activities for the project and ensures that members of the project team and management have a sufficient understanding of the M&S methods and results applied to the project
  • Manages consultants and outside collaborators that provide M&S expertise for individual tasks or entire projects.
  • Qualifications

    PhD in Biostatistics or Bioinformatics, or Medical Doctor degree, or PharmD with relevant experience in the planning and conduct of M&S projects for clinical study data preferably in a pharmaceutical industry setting.

  • Experience in planning and conduct of M&S projects for clinical study data
  • Experience with M&S programming tools such as R (e.g. nlme, nlmixr, saemix, mrgsolve, and tidyverse packages), Monolix, and / or NONMEM;
  • knowledge of Bayesian statistics and related programming tools (in particular rstan) would be an added value

  • Experience with modern scientific working processes (e.g. Git / github, LaTeX / markdown, parallel computing)
  • Highly effective team work and interpersonal skills (globally, internal and externally)
  • Highly effective oral and written communication, excellent presentation skills
  • Good knowledge of the drug development processes, as well as GCP and regulatory guidelines
  • Good knowledge of clinical pharmacology and relevant biological and medical concepts
  • Thinks broadly, strategically, and timely when preventing, solving or managing problems.
  • For further information please contact our Recruiting Team Switzerland : +41-61-682-2550

    Roche is an equal opportunity employer.

    Research & Development, Research & Development >

    Modelling & Simulation

    Roche is an equal opportunity employer.

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