Vacancy for Associate Scientist at Otsuka Pharmaceutical | Princeton, USA

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

Post : Associate Scientist

Responsibilities
The Assoc. Scientist/Scientist, Pharmacometrics will perform high quality pharmacometrics (PMx) analyses essential for internal decision making and successful approval with the support of his/her supervisor. He/she will represent PMx in project and trial teams as well as author PMx reports and develop PMx strategy with the support of his/her supervisor.

Job Responsibilities
• Develop PMx strategy and contribute to the clinical development plan, and implement model-informed drug discovery and development (MIDD) in clinical development projects with support of supervisor.
• Ensure timely delivery of PMx analyses for internal decision making throughout clinical drug development and registration with support of supervisor (e.g., non-linear mixed effects models, model-based meta analyses for dose selection, labeling, optimizing clinical study designs and pediatric development).
• Ensure timely delivery of PMx internal documents with support of supervisor. (e.g., dataset specification, PMx analysis plan, and PMx report).
• Ensure timely delivery of documents with support of supervisor. (e.g., clinical development plan, pediatric investigational plan, submission documents).
• Represent PMx in clinical development teams and in initiatives and working groups with support of supervisor.
• Organize and manage projects with external organizations with support of supervisor (e.g., academic institutions or CROs).

Candidate Profile
• Ph.D. Degree in, Pharmacometrics, Clinical Pharmacology, Mathematics, Biology, Statistics or equivalent area of focus
Knowledge
• Minimum of 0-2 years (Associate Scientist) 2 - 5 years (Scientist) hands on experience as a pharmacometrician in pharmaceutical industry, regulatory agency, or academia.
• Hands on modeling and simulation experience in PMx, PK/PD, clinical trial simulation and population based statistical analyses.
Skills
• Must be able to apply scientific knowledge (in the areas specified above) to further the company’s products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.
• Strong organization skills.
• Strong communication skills.
• Proficiency and ability to execute analysis in NONMEM and R
• Knowledge of other PMx softwares such a Monolix, SAS, PKSim, MATLAB, SimBiology, SimCYP
• Knowledge in clinical pharmacology, clinical drug development, MIDD, and regulatory guidelines
• Flexibility to react rapidly to changing situations/environment