Clinical Pharmacometrician

Department - Early Clinical Development
Location - Mölndal, Sweden

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world?s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The arena

This is a scientific job with responsibility for the population PK, PKPD, exposure-response and disease modelling in all clinical phases of Clinical Development. With support from a senior/principal pharmacometrician, the incumbent will be responsible for integrating emerging clinical data with existing preclinical models and literature data and developing mathematical/statistical models that will be used in model based drug development (MBDD).

The role

Typical Accountabilities

- Accountable for expert data analysis, interpretation, and reporting of results
- Input into pre-clinical, clinical, and post-approval development plans
- Use of a variety of innovative quantitative methods to integrate data of dose, pharmacokinetics, biomarkers, and clinical outcome (desirable and undesirable effects) with data of patient characteristics and knowledge of disease mechanisms and disease states to facilitate quantitative decision making
- Translate pre-clinical into clinical models, using emerging clinical data, to establish a model continuum
- Development of mechanistic disease models and dose-exposure-response models
- Use of M&S to influence study and program designs and decisions
- Writing and contributing to internal and regulatory submission documents related to M&S
- Compliance with Good Clinical Practice (GCP) regulations and guidances of regulatory authorities
- Evaluating of new data analysis techniques and software and integration into standard working practices
- Presentation and communication of results internally and externally at scientific meetings.

Minimum experience
- Demonstrated expertise in pharmacometrics
- Strong quantitative skills (e.g. experience in mechanistic modelling/systems pharmacology, quantitative translational scaling, literature meta-analyses, population modelling).
- Bachelor degree required with advanced degree preferred or equivalent relevant experience
- A clear demonstration of behaviours of
- Truth seeking rather than success seeking
- Agile responsiveness to scientific data
- Embracing of peer review
- Agnostic to internal-external sourcing

Preferred experience/requirements
- Early or late phase clinical development experience/awareness
- Recognised scientific expertise demonstrated by scientific publishing in the field on pharmacometrics

More information

For more information about the position please contact: Adriaan Cleton, +46 0)70 967 00 79.
Your application is welcome no later than March 9, 2014.