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Clinical Pharmacology Scientific Researcher

South San Francisco, CA 94080

Posted: 08/19/2022 Employment Type: Contract Job Number: 507211-1 Country: United States Is job remote?: No

Job Description


Description:
Duties

The Clinical Pharmacology (CP) Scientific Researcher is responsible for the delivery of PK/PD analyses and reports for their assigned development project[s], in order to ensure that appropriate dose/route/schedule decisions are made for the patients. The CP Scientific Researcher typically works under the supervision of a CP Scientist, in order to deliver the PK/PD elements of the agreed CP strategy. The CP Scientific Researcher works closely with colleagues in data programming, biostatistics and or infrastructure to facilitate the timely preparation and transfer of data sets containing PK/PD and critical patient demographic and treatment data for analyses. Performs other duties as assigned.

Skills
Technical Skills:
  • Familiarity with quantitative approaches in drug development, working knowledge of or a strong desire and ability to learn data programming tools (eg. NONMEM, WinNonlin, Berkeley Madonna, R, S-Plus, SimCYP, GastroPlus) and the ability to plan, organize and perform PK/PD data analyses.
  • Working knowledge of statistical approaches as they apply to clinical study design & analysis.
  • Working knowledge of relevant disease areas.

Communication Skills:
  • The CP Scientific Researcher requires strong communication skills, both written and oral, in order to deliver high quality protocols, regulatory documents, documents for team and management review, scientific manuscripts & posters for publication.

Drug Development Knowledge:
  • The CP Scientific Researcher should have a good knowledge of GCP and working knowledge of relevant regulatory guidelines.

Leadership:
  • Based on experience and ability, the CP Scientific Researcher may lead CP teams, project sub-teams and represent CP at cross-functional project teams.

Education
Qualifications:
  • BA or BS in Statistics, Mathematics, Biology, Chemistry, Pharmaceutical Sciences, Biomedical Engineering, or related quantitative discipline is required
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