About this role

About the role

Pharmacometrics Support (base)

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

We are seeking an experienced Pharmacometrics Support Programmer to join a global FSP team. This is an opportunity for a highly analytical programmer with strong R programming expertise and experience in PK/PD data preparation to contribute to critical drug development programmes.

In this role, you will be responsible for the creation, quality control, and standardisation of NONMEM PK/PD datasets, supporting pharmacometric modelling activities across a diverse clinical portfolio. Working closely with Data Management, Statistical Programming, Statistics, Bioanalytical teams, and external partners, you will play a key role in ensuring high-quality pharmacometric data is delivered on time and to the highest regulatory standards.

Key Responsibilities

Develop and quality control NONMEM PK/PD datasets using SDTM and ADaM data sources.
Support pharmacometric modelling activities by delivering accurate, complete, and submission-ready datasets.
Perform quality review of internally and externally produced NONMEM datasets.
Collaborate with Data Management, Statistical Programming, Statistics, Clinical Pharmacology, and Bioanalytical teams to resolve data issues and ensure project timelines are met.
Contribute to the preparation of regulatory submission projects in accordance with internal pharmacometrics guidelines.
Conduct quality control testing of customised R packages used to standardise pharmacometric workflows.
Develop and maintain testing frameworks and validation processes for departmental R tools and packages.
Identify data discrepancies, process improvements, and opportunities for greater automation and efficiency.
Actively contribute to the development and implementation of new pharmacometric standardisation initiatives.
Ensure all deliverables comply with applicable SOPs, working instructions, regulatory requirements, and ICH-GCP guidelines.
Maintain inspection readiness through ongoing training and adherence to quality standards.
What We're Looking For
Bachelor's degree in a Life Science, Health Science, Statistics, Computer Science, IT, or related discipline.
Minimum of 6 years' experience within the pharmaceutical, biotechnology, or CRO industry.
Strong programming expertise in R.
Experience developing and quality controlling NONMEM PK/PD datasets.
Working knowledge of PK/PD principles and pharmacometric workflows.
Strong understanding of SDTM, ADaM, and CDISC standards, including controlled terminology.
Experience supporting NONMEM file creation, quality control, submissions, and standardisation activities.
Strong attention to detail and commitment to data quality.
Excellent written and verbal communication skills in English.
Desired Skills
Experience reviewing and managing outsourced programming deliverables.
Experience validating or quality controlling customised R packages.
Demonstrated ability to identify process improvements and drive standardisation initiatives.
Ability to work effectively across global, cross-functional teams.
Why Join Us?
Opportunity to work within a globally recognised Clinical Pharmacology & Pharmacometrics function.
Contribute directly to innovative drug development programmes.
Work in a highly collaborative and scientifically driven environment.
Be part of ongoing innovation and standardisation initiatives within pharmacometrics and clinical data science.
Use your expertise to influence best practices and improve the efficiency and quality of pharmacometric deliverables.
If you are passionate about leveraging R programming, pharmacometrics, and data quality excellence to support drug development, we'd love to hear from you.

Location

Paris, Frankfurt, Dublin, Warsaw, Johannesburg, Reading

Reference: JR160092

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ICON Strategic Solutions (FSP)

Location

Taiwan, Taipei

Location

Taipei

Remote Working

Remote or Office

Business Area

ICON Strategic Solutions (FSP)

Job Categories

Clinical Programming

Job Type

Permanent

Description

As a Principal Statistical Programmer at ICON, you will be responsible for leading the design and implementation of statistical programming solutions that support clinical trials and regulatory submissions
Reference
JR162015
Expiry date
01/01/0001
Author
Huixin "Stella" Song
Author
Huixin "Stella" Song
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Statistical Programmer II (PK)

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Key Responsibilities

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