Senior Specialist - PKPD / Pharmacometric Data Programmer

AstraZeneca India; Singapore; Hybrid; SGD 80,000 - 115,000; Full time

Job summary

AstraZeneca India recherche un Senior Specialist en programmation PKPD qui aura un impact significatif sur le développement de médicaments. Le rôle inclut la préparation de données pour la modélisation et simulation pharmacométrique, avec des interactions réglementaires, en utilisant des outils avancés tels que NONMEM et SAS. Ce poste exige une expertise en programmation avec un minimum de 5 à 8 ans d'expérience dans le domaine, idéal pour ceux qui cherchent à allier innovation et collaboration dans un environnement dynamique.

Qualifications

• Expérience de 5 à 8 ans en programmation de données.
• Compétences avancées en SAS et R.
• Connaissance des normes CDISC, SDTM et ADaM.

Responsibilities

• Préparer et nettoyer les données pour la modélisation pharmacométrique.
• Contribuer à la documentation réglementaire.
• Assurer la conformité avec les réglementations GCP.

Skills

Communication orale et écrite en anglais

Préparation et programmation de données

Programmation SAS/R

Connaissance des pratiques de préparation de données

Expertise en développement clinique

Connaissance des processus réglementaires

Education

Licence ou Master dans un domaine pertinent

Tools

NONMEM

Monolix

R

Matlab

SAS

Python

Job description

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 data preparation, programming, validation, and diagnostics to support Pharmacometric and clinical pharmacology analyses at the study levels. You will influence 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. Responsibilities 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, internal initiatives to develop the Pharmacometric discipline, and ensure 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 Master's preferred with 5 to 8 years relevant experience
• Knowledge of 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 pharmacometrics
• Knowledge in pharmacology, drug targets, and core therapy areas (e.g., Oncology, Respiratory, Renal, Metabolism)
• Relevant regulatory experience

We embrace in-person collaboration, working a minimum of three days per week from the office, while respecting individual flexibility. Join us in our innovative and ambitious environment at AstraZeneca, where we fuse data, technology, and scientific discovery to develop life-changing medicines. If you're ready to make an impact, apply now and be part of this exciting journey!