Senior Product Analyst – Clinical Pharmacology / Pharmacometrics

Experience: 8-12 yrs

Location: Pune / Noida / Hyderabad / Bengaluru / Chennai

JD-

Position Overview:

We are seeking a Senior Product Analyst with a strong foundation in Clinical Pharmacology, Pharmacometrics modelling concepts, and hands-on experience with simulation tools and PK/PD data analysis. The ideal candidate will work closely with scientists, modelers, and product teams to support the design, validation, and enhancement of pharmacometrics modelling platforms, including Phoenix WinNonlin, Monolix, NONMEM, and R-based analytical tools.

Key Responsibilities:

• Collaborate with scientific users, cloud engineers, and product owners to define and validate requirements for modelling platforms and analytical tools.
• Serve as the subject matter expert (SME) for Clinical Pharmacology and Pharmacometrics modelling and simulation workflows.
• Perform hands-on analysis and validation of PK/PD datasets, ensuring scientific accuracy and compliance with data standards.
• Assist in developing and refining standardized workflows for modelling and simulation using Phoenix WinNonlin, Monolix, NONMEM, and R-based tools (Shiny apps, R Markdown reports, etc.).
• Translate pharmacology use cases into technical and functional requirements for software or platform enhancements.
• Collaborate with regulatory and data standards teams to ensure alignment with CDISC SDTM/ADaM and data integrity principles.
• Support model-informed drug development (MIDD) initiatives by ensuring analytical consistency and reproducibility across studies.

Required Skills & Experience:

Domain Expertise:

• Strong understanding of Clinical Pharmacology principles, including pharmacokinetics (PK), pharmacodynamics (PD), exposure–response relationships, and dose optimization.
• Hands-on familiarity with pharmacometric modelling and simulation tools, including:
• Phoenix WinNonlin / Phoenix NLME
• Monolix Suite (Monolix, Simulx, PKanalix)
• NONMEM (model structure, estimation methods, and control streams)
• R-based tools for statistical analysis, automation, and visualization (R, RStudio, Shiny, ggplot2, etc.)
• Understanding of PK/PD models, compartmental modelling, and population pharmacokinetic analysis.
• Experience interpreting modelling outputs, preparing analysis summaries, and contributing to clinical pharmacology reports.
• Familiarity with simulation technologies, reproducibility, and workflow automation for modelling studies.

Technical and Product Skills:

• Experience supporting or validating analytical workflows on cloud-based HPC environments (AWS preferred).
• Understanding of scientific software integration, job automation, and data flow between modelling tools and databases.
• Ability to write and review user stories, test scripts, and validation documents for platform features.
• Knowledge of Agile delivery practices and tools such as Jira, Confluence, and Bitbucket.

Regulatory & Data Standards Awareness:

• Awareness of CDISC SDTM and ADaM standards and their application in Clinical Pharmacology datasets.
• Understanding of 21 CFR Part 11, GxP, and data integrity requirements for regulated analytical systems.

Education:

• Master’s or Bachelor’s degree in Pharmacy, Pharmacology, Pharmaceutical Sciences, Biomedical Engineering, or Computational Biology.
• Additional certifications or coursework in Pharmacometrics, Clinical Pharmacology, or R programming are highly desirable.

Job Types: Full-time, Permanent

Pay: From ₹1,500,000.00 per year

Application Question(s):

• How many years of experience do you have in Phoenix WinNonlin, Monolix, NONMEM, and R-based tools?
• Have you applied or attended the interview in Birlasoft in last 6 months?
• What is your current CTC?
• What is your expected CTC?
• What is your current and preferred location?
• Are you ok with the third-party payroll?
• How many years of total experience do you currently have?
• How many years of experience do you have in Clinical Pharmacology, Pharmacometrics modelling concepts?
• What is your notice period/ LWD?