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!
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