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Title:Sr Principal Biostatistician
Location:NJ - East Hanover

Support projects and functions throughout Research & Development, including compound selection, exploratory clinical development, and late development, with model-based planning, clinical trial design, evaluations, integrated analysis, and reporting. Support decision-making by pre-clinical or clinical teams with Modeling & Simulation (M&S)-based input.

  • Develop, evaluate and report models that describe compound- or disease-related data. The spectrum of models employed includes, but is not limited to, mixed effects models (e.g. population PK/PD), Bayesian Statistics, Decision Analysis, mechanistic or physiological, biochemical, biophysical, PK/PD.
  • Apply established or dedicated M&S techniques to data of an in vitro, in vivo, and/or clinical nature, acquired from disease- or compound-specific studies.
  • At project levels, provide support for phase transitions and/or development plans.
  • Support decision-making on projects and/or trials with M&S-based input.
  • In a Clinical setting, provide study design support for clinical trial development.
  • Provide relevant expertise and represent M&S as a member of various R&D Project teams.
  • Interact with Health Authorities and external collaborators as appropriate.
  • Support and defend analyses and interpretations at Health Authorities meetings.
  • Actively contribute to the reviewing and implementation of regulatory guidances.
  • Demonstrate scientific leadership in M&S activities for R&D projects.
  • Identify and implement opportunities for innovative study designs and M&S applications.
  • Sustain scientific competence by establishing familiarity with new methods, continuing education in the field of expertise.
  • Ensure the integration and sharing of M&S tools and developments within all M&S groups as well as other R&D functions.
  • Lead evaluation of new M&S tools.

  • Experience in applying M&S to drug R&D in PK/PD.
  • Knowledge in several of the following modeling areas: statistics, learning algorithms, PK/PD, molecular pathways, biology, tissue effects, pathophysiology
  • Knowledge of the drug R&D process, including clinical development modeling and HA guidelines, as relevant to M&S
  • Background medical knowledge
  • Knowledge of relevant software packages
  • Good data exploration skills. Ability to understand heterogeneous data and communicate effectively with people from diverse scientific backgrounds in a multi-disciplinary organization; ability to interact effectively with both management and teams to constructively influence decision-making
  • Exceptional written and verbal communication skills including the ability to interact effectively with a multidisciplinary team
  • Good business ethics
  • Innovative attitude; creative approach to model implementation
  • Welcomes problems as challenges; able to approach problems from multiple angles
  • Well-developed organizational skills; able to manage several projects simultaneously
  • Required years of experience One (1) - Three (3) Years

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