Senior PK/PD Modeling & NONMEM Programmer

Cytel; United Kingdom; On-site; GBP 70,000 - 100,000; Full time

Job summary

Cytel in the United Kingdom is seeking a Senior Statistical Programmer embedded with a pharmaceutical client to drive PK/PD modeling and e-submission preparations.

You will generate NONMEM input datasets, perform data cleaning, coordinate with PM/CPP leads, and ensure deliverables meet regulatory requirements.

This role requires extensive SAS programming experience in clinical trials, CDISC standards, and the ability to work across globally dispersed teams.

Qualifications

• Proven SAS programming experience for clinical trials.
• Strong data manipulation, analysis and reporting skills.
• Experience implementing CDISC SDTM/ADaM standards.
• QC/validation of datasets and outputs.
• Experience with define.xml and submission documents.
• Ability to work in a globally distributed team.

Responsibilities

• Prepare programming scripts (e.g. R, SAS) to generate NONMEM analysis input datasets for PK/PD analyses.
• QC NONMEM input datasets generated by other PM support; document QC findings.
• Generate e-submission package for NONMEM analysis and ensure correct structure and naming.
• Provide guidance to junior CPP members for the DataFlow process.
• Provide guidance for Data Collection Tools review process.
• Interact with Data Management, Programming, BAN/BDS, EPOD and external Vendors to support CPP needs.
• Revise, update and create SOPs, templates, training materials for CPP processes.
• Improve CPP processes in dataset creation, QC, and e-submission packaging.
• Support secure exchange medium setup.

Skills

SAS programming

Data manipulation

Analysis & reporting

CDISC SDTM/ADaM

QC/validation

Ad-hoc reporting

Efficacy analysis

Cross-functional collaboration

Troubleshooting

Education

Bachelor’s degree in Statistics / Computer Science / Mathematics

At least 6 years SAS programming in Pharma/Biotech (BA)

At least 4 years with a master’s degree

Tools

SAS

Job description

Cytel in the United Kingdom is seeking a Senior Statistical Programmer embedded with a pharmaceutical client to drive PK/PD modeling and e-submission preparations.

You will generate NONMEM input datasets, perform data cleaning, coordinate with PM/CPP leads, and ensure deliverables meet regulatory requirements.

This role requires extensive SAS programming experience in clinical trials, CDISC standards, and the ability to work across globally dispersed teams.