Overview
Support Clinical Pharmacology & Pharmacometrics leaders with technical and operational work on PK, PD and PK/PD modelling and simulation across all therapeutic areas, focused on data assembly, dataset quality control and regulatory e-submission support.
What you'll do
- Support CPP trial deliverables across all therapeutic areas, primarily post-interim and final database release, by preparing analysis-ready datasets for PK and/or PD analyses (ADNCA & NONMEM).
- Perform basic Pharmacometrics analysis QC activities, including documentation of QC checks, findings, and follow-up actions.
- With oversight, support global regulatory submissions by preparing population PK/PD and Exposure Response e-submission packages, including datasets, control files, outputs, tables, and supporting documentation.
- Assist in process improvement initiatives, software validation and other technology improvements.
- Carry out functional responsibilities in accordance with applicable SOPs, regulatory requirements and Johnson & Johnson Credo principles.
What you'll need
- Bachelor's degree (or equivalent) in a scientific discipline.
- 1-3 years of experience in the pharmaceutical industry.
- Basic proficiency in R for data manipulation.
- Basic understanding of SDTM and ADaM clinical data structures.
- Basic understanding of ADNCA & NONMEM input dataset requirements.
- Good understanding of non-linear mixed-effects modeling.
- Good understanding of clinical PK and PK/PD concepts.
- Good understanding of clinical drug development processes.
- Clear written and verbal communication skills.
- Strong attention to detail and quality mindset.
- Ability to work effectively in cross-functional teams.
- Effective planning, prioritization, and multitasking skills.
- Accountability for timely delivery of assigned tasks.
- Continuous learning mindset and openness to process improvement.
- Cultural awareness and ability to work in global teams.
- Ability to work independently with oversight.
- Fluent in English, plus local language requirements as applicable.
Nice to have
- 1-3 years of experience preferably within Clinical Pharmacology, Pharmacometrics, or data analysis support roles.
Details
- Location: Hyderabad, Andhra Pradesh, India.
- Oversight of a senior Pharmacometrics Support Programmer.
- Travel: approximately 5%.
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