Associate Director, PKPD / Pharmacometric Data Programming

Company: AstraZeneca GmbH
Location: Gaithersburg
Posted on: October 8, 2024

Job Description:

Job Title: Associate Director, PKPD / Pharmacometric Data ProgrammingCareer Level - EIntroduction to Role:Are you ready to make a significant impact in the world of drug development? We are seeking an Associate Director for PKPD / Pharmacometric Data Programming. This role focuses on all aspects of data preparation, programming, validation, and diagnostics to support Pharmacometric and clinical pharmacology analyses at the study and project levels. You will be instrumental in influencing critical decision making throughout all phases of drug development and regulatory interactions.Accountabilities:As an Associate Director, you will be accountable for expert data integration, manipulation, and preparation results at the study and project level. You will execute state-of-the-art data preparation techniques with direct value for the study and/or project. Your responsibilities will include collating, cleaning, and preparing analysis-ready data for Pharmacometric Modeling and Simulation (M&S) software (e.g. NONMEM) to influence study designs and go/no-go decisions. You will also contribute to regulatory documents and interactions, internal initiatives to develop the Pharmacometric discipline, and compliance with Good Clinical Practice (GCP) regulations.Essential Skills/Experience:

• Proficient oral and written English communication skills
• Demonstrated expertise in data preparation and programming to support Pharmacometric Modeling and Simulation (M&S) software (e.g. NONMEM, Monolix, R, Matlab)
• Strong SAS/R programming skills
• Expert knowledge of data preparation and programming practices (CDISC, SDTM, ADaM)
• Demonstrated data programming and clinical development expertise
• Good knowledge of global regulatory, compliance, processes, standards
• Bachelor's degree MS preferred with relevant experience required
• Relevant regulatory experience
• Varied programming languages (SAS, R, Python)
• Experience in early and late-stage drug development
• Knowledge in pharmacology, drug targets and core Therapy areas (e.g. Oncology, Respiratory, Renal Metabolism etc.)
• Quantitative/Scientific background (Statistics, Engineering, Biological Science)Desirable:
• Scientific publishing in the field on pharmacometrics
• Project Management SkillsReady to make a difference? Apply today and join us in pushing the boundaries of science to deliver life-changing medicines!
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Keywords: AstraZeneca GmbH, Centreville , Associate Director, PKPD / Pharmacometric Data Programming, Executive , Gaithersburg, Virginia