Description
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Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Pharmacokinetics & PharmacometricsJob Category:
Scientific/TechnologyAll Job Posting Locations:
PENJERLA, Telangana, IndiaJob Description:
Clinical Pharmacology & Pharmacometrics (CPP)
Scientist Pharmacometrics Support - Hyderabad
(*Title may vary based on Region or Country requirements)
Position Summary:
The Scientist, Pharmacometrics Support provides technical support to CPP exploring automations of day-to-day deliverables. The role focuses on operational efficiencies to speed up data assembly, dataset quality control, documentation readiness, and submission-support document deliverables, ensuring timely, compliant, high-quality outputs aligned with internal standards and global regulatory expectations.
In addition, the role contributes to workflow modernization, including the application of automation and AI-enabled assistance to improve the efficiency, consistency, and traceability of basic data structures, documentation, and quality checks.
Principal Responsibilities:
- Standardize programming R scripts & functions to generate ADNCA & NONMEM input datasets from SDTM, ADaM, or other source formats, using GenAI.
- Create a default routine to generate a variable definition documentation to support submission package creation.
- Perform basic Pharmacometrics QC activities on AI generated code, including documentation of QC checks, findings, and follow‑up actions.
- Contribute suggestions for process improvements, including automation and standardization of scripts and tools.
- Support updates to SOPs, job aids, templates, and training materials as needed.
- Follow applicable CPP processes, SOPs, and regulatory instructions.
Principal Relationships:
Internal: CPP Clinical Pharmacology & Pharmacometrics Leaders, CPP Scientists.
External: not applicable.
Education and Experience Requirements:
Bachelor’s degree (or equivalent) in a scientific discipline
1-2 years of experience in the pharmaceutical industry, preferably within Clinical Pharmacology, Pharmacometrics, or data analysis support roles
Minimum Technical Knowledge and Skills
- Proficiency in R for data manipulation is preffered
- basic knowledge of SDTM and ADaM clinical data structures
- basic 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
- Accountability for timely delivery of assigned tasks
- Continuous learning mindset and openness to process improvement
- Ability to work independently with minimal supervision
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