Senior Specialist - PKPD / Pharmacometric Data Programmer

AstraZeneca GmbH; Birmingham; On-site; GBP 45,000 - 75,000; Full time

Job summary

An established industry player is seeking a Senior Specialist Programmer for PKPD/Pharmacometric Data Programming. This pivotal role involves data preparation, programming, and validation to support critical pharmacometric analyses in drug development. You will engage with various software tools to ensure data integrity and compliance, influencing decision-making across all drug development phases. If you have a strong background in programming, data standards, and a passion for making a significant impact in the field of pharmacometrics, this is the perfect opportunity for you.

Qualifications

• 5-8 years of relevant experience in drug development.
• Expertise in programming and data preparation for pharmacometric analyses.

Responsibilities

• Responsible for data integration, manipulation, and preparation.
• Contributing to regulatory documents and ensuring compliance with GCP.

Skills

Data preparation for Pharmacometric Modeling

Programming in SAS

Programming in R

Programming in Python

Communication skills

Data standards knowledge (CDISC, SDTM, ADaM)

Understanding of regulatory requirements

Experience in clinical development

Statistical background

Education

Bachelor’s degree

Master’s degree

Tools

NONMEM

Monolix

Matlab

Job description

Senior Specialist - PKPD / Pharmacometric Data Programmer

Birmingham

GBP 45,000 - 75,000

Introduction to role:

Are you ready to make a significant impact in the world of drug development? We are seeking a Senior Specialist Programmer for PKPD / Pharmacometric Data Programming. This role focuses on data preparation, programming, validation, and diagnostics to support Pharmacometric and clinical pharmacology analyses at the study level. You will influence critical decision-making throughout all phases of drug development and regulatory interactions.

Accountabilities:

As a Senior Specialist Programmer, you will be responsible for data integration, manipulation, and preparation at the study level. Your duties include collating, cleaning, and preparing analysis-ready data for Pharmacometric Modeling and Simulation (M&S) software (e.g., NONMEM). You will contribute to regulatory documents, internal initiatives, and ensure compliance with GCP regulations.

• Proficient in oral and written English communication
• Expertise in data preparation and programming for Pharmacometric Modeling and Simulation software (e.g., NONMEM, Monolix, R, Matlab)
• Knowledge of data standards (CDISC, SDTM, ADaM)
• Experience in data programming and clinical development
• Understanding of global regulatory requirements and standards
• Bachelor’s or Master’s degree with 5-8 years of relevant experience
• Proficiency in programming languages (SAS, R, Python)
• Experience in early and late-stage drug development
• Background in Statistics, Engineering, or Biological Sciences
• Publication record in pharmacometrics
• Knowledge of pharmacology, drug targets, and therapy areas (e.g., Oncology, Respiratory, Renal)
• Relevant regulatory experience

Ready to make an impact? Apply now and join us on this exciting journey!