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Role Description

We are seeking an experienced Senior PK/PD Programmer to support pharmacokinetic (PK) and pharmacodynamic (PD) analyses across clinical development programs. This role is responsible for creating analysis datasets, generating tables/listings/figures (TLFs), supporting modeling activities, and ensuring high-quality deliverables for regulatory submissions.

• Develop and validate PK/PD analysis datasets (ADaM, SDTM as applicable).
• Generate Tables, Listings, and Figures (TLFs) for PK/PD studies.
• Support population PK, exposure-response, and other modeling analyses.
• Perform data cleaning and reconciliation between clinical and PK datasets.
• Ensure compliance with CDISC standards (SDTM, ADaM).
• Support pharmacometricians in NONMEM, Monolix, or similar modeling platforms.
• Prepare analysis-ready datasets for modeling.
• Assist with model diagnostics, simulations, and reporting outputs.
• Create graphical outputs for clinical study reports and regulatory submissions.
• Perform QC and validation of programming outputs.
• Support regulatory submissions (IND, NDA, BLA, etc.).
• Maintain documentation for programming activities.
• Work closely with Clinical Pharmacology, Biostatistics, Data Management, and Medical Writing teams.
• Participate in study team meetings and provide programming input.
• Mentor junior programmers when needed.

Qualifications

• 5–8+ years of programming experience in clinical trials.
• 3+ years of PK/PD programming experience.
• Experience with NMPKPD and ER datasets.
• Experience in Early-Stage Development studies.
• Experience with R programming preferred.
• Working knowledge of NONMEM, Monolix, Phoenix WinNonlin, or similar tools.
• Experience with CDISC standards (SDTM, ADaM).
• Strong data manipulation and visualization skills.

Education

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field.

The Application Process

• Once you have submitted your CV, you will receive an acknowledgement that we received it.
• If you have the requirements we need, you will be invited for phone interview as the first step.
• Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Company Description

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.