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 looking for a Senior Specialist Programmer to make a significant impact in drug development. This role focuses on data preparation and programming for Pharmacometric Modeling and Simulation, utilizing advanced techniques to support critical decision-making in drug development phases. You will be responsible for preparing analysis-ready data and ensuring compliance with regulatory standards. Join a dynamic team that is dedicated to innovation and excellence in the pharmaceutical field, where your contributions will play a vital role in shaping the future of healthcare.

Qualifications

• 5-8 years of relevant experience in data programming and clinical development.
• Expertise in CDISC, SDTM, ADaM data practices.

Responsibilities

• Accountable for data integration and preparation for Pharmacometric Modeling.
• Contribute to regulatory documents and compliance with GCP regulations.

Skills

Data preparation

Programming (SAS/R)

Communication skills

Pharmacometric Modeling and Simulation

Knowledge of GCP regulations

Quantitative/Scientific background

Programming languages (SAS, R, Python)

Education

Bachelor’s degree

Master’s degree

Tools

NONMEM

Monolix

R

Matlab

Job description

Job Title: Senior Specialist - PKPD / Pharmacometric Data Programmer

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 all aspects of data preparation, programming, validation, and diagnostics to support Pharmacometric and clinical pharmacology analyses at the study levels. You will be instrumental in influencing critical decision-making throughout all phases of drug development and regulatory interactions.

Accountabilities:

As a Senior Specialist Programmer, you will be accountable for expert data integration, manipulation, and preparation results at the study level. You will execute state-of-the-art data preparation techniques with direct value for the study. Your responsibilities will include collating, cleaning, and preparing analysis-ready data for Pharmacometric Modeling and Simulation (M&S) software (e.g., NONMEM) to influence study designs and go/no-go decisions. You will also contribute to regulatory documents and interactions, internal initiatives to develop the Pharmacometric discipline, and compliance with Good Clinical Practice (GCP) regulations.

Essential Skills/Experience:

• Proficient oral and written English communication skills
• Demonstrated expertise in data preparation and programming to support Pharmacometric Modeling and Simulation (M&S) software (e.g., NONMEM, Monolix, R, Matlab)
• Strong SAS/R programming skills
• Expert knowledge of data preparation and programming practices (CDISC, SDTM, ADaM)
• Demonstrated data programming and clinical development expertise
• Good knowledge of global regulatory, compliance, processes, standards
• Bachelor’s degree or Masters preferred with 5 to 8 years relevant experience required
• Varied programming languages (SAS, R, Python)
• Experience in early and late-stage drug development
• Quantitative/Scientific background (Statistics, Engineering, Biological Science)

Desirable Skills/Experience

• Scientific publishing in the field of pharmacometrics
• Knowledge in pharmacology, drug targets, and core Therapy areas (e.g., Oncology, Respiratory, Renal Metabolism etc.)
• Relevant regulatory experience

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