Statistical Programmer

Warman O'Brien; United States; Remote; GBP 65.000 - 110.000; Vollzeit

Benefits dieser Stelle

Fully remote across Europe

Global Pharmacometrics team

Career development

Zusammenfassung

Warman O'Brien is seeking a Senior PK/PD Programmer to join a sponsor-dedicated FSP with a leading CRO/pharma partner. The role is fully home-based across Europe, including the UK, with ongoing global pharmacometrics initiatives.

You will program and QC NONMEM PK/PD datasets, perform QC, and collaborate with Clinical Pharmacology, Data Management and Statistics teams to support regulatory submissions. 4+ years in pharma/CRO is required.

Qualifikationen

• Essential PK/PD programming experience in pharma/CRO.
• Strong R programming skills and NONMEM experience.
• Familiarity with SDTM/ADaM datasets and regulatory submissions.

Aufgaben

• Program and QC NONMEM PK/PD datasets from SDTM/ADaM inputs.
• Deliver accurate PK/PD data within timelines.
• QC outsourced NONMEM datasets and contribute to standards.
• Support pharmacometrics projects for regulatory submissions.
• Collaborate with Pharmacology, Data Management and Statistics teams.

Kenntnisse

PK/PD programming

R programming

NONMEM

Clinical pharmacology

Ausbildung

Degree in health/science/IT

Tools

NONMEM

R

SDTM/ADaM

Jobbeschreibung

Senior PK/PD Programmer | FSP | Leading CRO / Top Pharma | Home Based | UK & Europe |

An exciting opportunity to join a leading global CRO within a sponsor-dedicated FSP model, working exclusively with a top pharma.

We are looking for an experienced Senior PK/PD Programmer to support a global Pharmacometrics team within Clinical Pharmacology & Pharmacometrics.

This specialist position will focus on the programming and QC of high-quality PK/PD NONMEM datasets, alongside R programming and supporting Pharmacometrics activities. You will work closely with Pharmacometrics, Data Management, Statistical Programming and Bioanalytical teams.

Previous PK/PD experience is essential for this role, and interviews are taking place immediately.

What you will be doing:

• Program and QC NONMEM PK/PD datasets based on SDTM and ADaM datasets.
• Deliver accurate, complete and high-quality NONMEM input data within agreed timelines.
• Work with datasets both before and after database lock.
• Perform QC of outsourced NONMEM datasets.
• Support the preparation of Pharmacometrics projects for regulatory submissions.
• QC customised R packages used to standardise Pharmacometrics activities.
• Review programming requirements and data, identify gaps and recommend solutions.
• Contribute to Pharmacometrics programming standards and process improvements.
• Collaborate with Clinical Pharmacology, Data Management, Statistics, Statistical Programming teams.

What you will need:

• Previous PK/PD | Pharmacokinetics experience is essential.
• Strong R programming experience.
• Experience programming and/or QCing NONMEM datasets.
• Good knowledge of PK/PD principles and clinical trial concepts.
• Knowledge of SDTM, ADaM and controlled terminology.
• Previous experience with NONMEM file creation, standardisation, submissions and QC.
• 4+ years of relevant pharmaceutical, biotech or CRO industry experience
• Degree in a health, science, IT or related discipline.
• Excellent attention to detail and strong communication skills.

What’s in it for you:

• Opportunity to work within a dedicated FSP model for a top pharmaceutical company.
• Specialist position within a global Pharmacometrics environment.
• Fully home-based across Europe.
• Excellent long-term career development and progression opportunities.
• Opportunity to work closely with experienced global Clinical Pharmacology and Pharmacometrics teams.