Scientist Pharmacometrics Support - Hyderabad in Hyderabad, भारत
Johnson & Johnson
Hyderabad, भारत
Johnson & Johnson seeks a Scientist in Pharmacometrics Support to provide technical assistance with pharmacokinetic and pharmacodynamic modeling activities. The role involves dataset preparation, quality control, and regulatory submission support across clinical development programs, located in Hyderabad.
Responsibilities
Prepare analysis-ready datasets for pharmacokinetic and pharmacodynamic analyses post-database release
Perform quality control activities on pharmacometric analyses with documentation of findings
Support regulatory submissions by assembling population PK/PD e-submission packages
Contribute to process improvement initiatives and software validation efforts
Execute responsibilities in accordance with standard operating procedures and regulatory requirements
Requirements
Bachelor's degree in scientific discipline
1–3 years pharmaceutical industry experience in clinical pharmacology or data analysis
Proficiency in R for data manipulation
Understanding of SDTM, ADaM, ADNCA, and NONMEM data structures
Knowledge of nonlinear mixed-effects modeling and clinical PK/PD concepts
Strong written and verbal communication with attention to detail
Fluent English; ability to work in global cross-functional teams
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