Scientist, Pharmacometrics Support

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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Pharmacokinetics & Pharmacometrics

Job Category:

Scientific/Technology

All Job Posting Locations:

PENJERLA, Telangana, India

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