Scientist Pharmacometrics Support - Hyderabad

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Job Function
Discovery & Pre-Clinical/Clinical Development
Job Sub Function
Pharmacokinetics & Pharmacometrics
Job Category
Scientific/Technology
All Job Posting Locations:
Hyderabad, Andhra Pradesh, India
Job Description
Clinical Pharmacology & Pharmacometrics (CPP)
Scientist Pharmacometrics Support - Hyderabad
Position Summary
The Scientist, Pharmacometrics Support, provides technical and operational support to Clinical Pharmacology & Pharmacometric leaders in the execution of PK, PD, and PK/PD modelling and simulation activities across all therapeutic areas. The role focuses on data assembly, dataset quality control, and regulatory e‑submission support, ensuring timely, compliant, and high‑quality trial and submission deliverables in accordance with CPP standards and global regulatory requirements with oversight of a senior Pharmacometrics Support Programmer
This role supports trial and submission deliverables post‑interim and final database release, applies established CPP processes, and contributes to continuous process improvement within CPP.
Principal Responsibilities
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 & Exposure Response e‑submission packages, including datasets, control files, outputs, tables, and supporting documentation.
Assists 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.
Principal Relationships
Internal: CPP Clinical Pharmacology & Pharmacometrics Leaders, CPP Scientists, Data Management, Clinical & Statistical Programming, Bioanalysis (BDDS), Regulatory & Publishing teams.
External: PK office vendors and other external stakeholders.
Education And Experience Requirements
Bachelor’s degree (or equivalent) in a scientific discipline
1–3 years of experience in the pharmaceutical industry, preferably within Clinical Pharmacology, Pharmacometrics, or data analysis support roles
Minimum Technical Knowledge And Skills
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
Clinical PK and PK/PD concepts
Clinical drug development processes
Minimum Non‑Technical Competencies And Skills
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
Other
Language requirements: fluent in English, local language requirements as applicable.
Travel: Approximately 5%
Required Skills
Preferred Skills:
Analytical Reasoning, Clinical Data Management, Clinical Operations, Clinical Pharmacology, Data Savvy, Detail-Oriented, Drug Discovery Development, Execution Focus, Pharmacokinetic Modeling, Pharmacokinetics, Pharmacometrics, Regulatory Environment, Relationship Building, Report Writing, Scientific Research, Study Management, Technologically Savvy

Work arrangement
Hybrid