Associate Director, PKPD / Pharmacometrics / NONMEM / SAS Programmer

Role Overview: You are being offered the opportunity to join as an Associate Director, PKPD / Pharmacometrics / NONMEM / SAS Programmer in the Clinical Pharmacology and Quantitative Pharmacology Data Programming team. Your main responsibility will be to prepare, program, validate, and diagnose data to support Pharmacometrics and Clinical Pharmacology analyses. Your influence will be vital in shaping crucial decision-making processes throughout all stages of drug development and regulatory interactions. Key Responsibilities: - Expertly clean, manipulate, transform, and integrate data at both the study and compound level to ensure accurate analysis. - Utilize advanced data integration techniques to pool data from study and compound-level SDTM/ADaM datasets, preparing analysis-ready data for Pharmacometrics Modeling and Simulation (M&S) software like NONMEM. - Play a pivotal role in informing study design, dose selection, dose justification, and guiding go/no-go decisions through your data preparation efforts. - Contribute to regulatory documents and internal initiatives aimed at advancing the Pharmacometrics discipline and ensuring compliance with Good Clinical Practice (GCP) regulations. Qualification Required: - Bachelor's degree, with an MS preferred, along with relevant experience. - 10+ years of hands-on experience in SAS programming for preparing pooled data sets across studies. - Strong understanding of pharmacokinetics, pharmacodynamics, and their applications in drug development. - Proficiency in SAS/R programming, as well as varied programming languages like SAS, R, and Python. - Expert knowledge of data preparation and programming practices such as CDISC, SDTM, and ADaM. - Demonstrated experience in regulatory submissions and interdisciplinary team leadership. - Good knowledge of global regulatory compliance processes and standards. - Capability to develop tools for data integration and visualization. - Experience in early and late-stage drug development. - Excellent problem-solving, communication, and project management skills. - Proficient oral and written English communication skills. - Knowledge in pharmacology, drug targets, and core therapy areas like Oncology, Respiratory, Renal Metabolism, etc. - Quantitative/scientific background in Statistics, Engineering, or Biological Science. Additional Company Details: At AstraZeneca, the focus is on fusing data and technology with scientific innovation to achieve breakthroughs in healthcare. The dynamic and inclusive environment encourages creativity, bold decision-making, and collaboration to create impactful solutions for patients globally. The company is committed to making a difference in healthcare by transforming the future through science and innovation.,