Scientist Pharmacometrics Support - Hyderabad

Johnson & Johnson Co.; Hyderabad; Presencial; INR 1.200.000 - 2.400.000; Jornada completa

Descripción de la vacante

The Scientist, Pharmacometrics Support at Johnson & Johnson in Hyderabad provides technical and operational support to CPP leaders in PK, PD, and PK/PD modelling across therapeutic areas. The role focuses on data assembly, dataset quality control, and regulatory e-submission support to ensure timely, compliant trial deliverables.

You will work post-interim and final database releases, apply CPP processes, and contribute to ongoing process improvements.

Formación

• Bachelor's degree in a scientific discipline
• 1-3 years of pharmaceutical industry experience in Clinical Pharmacology, Pharmacometrics, or data analysis support roles
• Basic proficiency in R for data manipulation and understanding of SDTM/ADaM structures

Responsabilidades

• Prepare analysis-ready datasets for PK/PD analyses (ADNCA & NONMEM).
• Perform basic Pharmacometrics QC activities with documentation.
• Support population PK/PD & Exposure Response e-submission packages for regulatory submissions.
• Assist in process improvement initiatives and software validation.
• Adhere to SOPs, regulatory requirements, and Credo principles.

Conocimientos

R

NONMEM

SDTM/ADaM

PK/PD modelling

Drug development

Educación

Bachelor's degree in science

Descripción del empleo

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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%

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