Senior Specialist - PKPD / Pharmacometric Data Programmer

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

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are committed to making a difference. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. It's our combination of curiosity and courage that drives us, inspired by the possibility of doing things that have never been done before. Empowered to step up, we free ourselves from fear of failure to dig deep into the biology of complex diseases and make bold decisions. Celebrating our successes and failures along the way.

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