Conceive and execute statistical and mathematical models that achieve projects, Clinical Pharmacology and Pharmacometrics goals. Propose PK/PD modeling and simulation ideas and implement those efforts. Investigate, identify, develop, and optimize methods and techniques in the field of PK/PD modeling. Act as a lead pharmacometrician in his/her area of expertise and critically evaluate relevant Pharmacometric, PK/PD, Clinical Pharmacology and regulatory advances and integrate this knowledge into Clinical Pharmacology strategy for research or development programs

Responsibilities

Contribute to clinical development by supporting Phase 1-4 studies with data analysis, modeling and simulation evaluations to guide study design, and clinical pharmacology strategy.

• Author regulatory documents including analysis plans, study reports, population PK reports, exposure-response analyses reports, common technical documents, white papers, and other similar documents.
• Conduct data analyses including non-compartmental analyses, modeling and simulation, advanced analytics, as well as literature data analyses.
• Participate and present at various departmental and cross functional teams such as Clin Pharm meetings, Journal club.
• Collaborate with scientific support from other Clinical Pharmacology functional groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams.
• Author scientific publications and present at scientific conferences