Senior SAS Programmer (PK/PD & NONMEM required)
This position focuses on all aspects of data preparation, programming, validation and diagnostics to support pharmacometric and clinical pharmacology analyses at the study level to influence critical decision making throughout all phases of drug development and regulatory interactions. This person will support data preparation for pharmacometric analyses (Population PK, modelling and simulation, model-based and mechanistic knowledge), clinical pharmacokinetic activities, quantitative systems pharmacology (QSP) modelling, drug disease modelling and exploring machine learning and artificial intelligence approaches.
Works directly with the pharmacometricians and clinical pharmacology scientists providing data support. Implements and supports standards and a harmonized approach to programming.
With support from the Principal Pharmacometrician and the TA lead, the incumbent will be responsible for integrating internal (and external) data to support interpretation and decision making at the study level and with some support at the project level.
- Accountable for expert data integration, manipulation and preparation results at the study level
- Collates, cleans and prepares data to support M&S to influence study designs and go/no go decisions and support development of (mechanistic) drug-disease models within a specific disease domain
- Contribute to regulatory documents and interactions (written)
- Contribute to internal initiatives to develop the pharmacometric discipline including its processes
- Participation in peer review of ongoing activities, reports and presentations
- Compliance with Good Clinical Practice (GCP) regulations as well as internal/external guidance’s
- Build infrastructure, software and standards using programming macros
- Recommend tools, updates and upgrades
- Occasional interactions with leaders as clinical experts
- Engage with vendors on data delivery and technical issue and data transfers
- Strong SAS programming skills
- Demonstrated expertise in data preparation and programming to support pharmacometrics, including PK, PKPD and/or statistics
- BSc or post graduate qualification (or local equivalent) in Mathematics, Statistics, Informatics, Life or Social Sciences, or equivalent experience
- Demonstrated data programming and clinical development expertise and experience exemplified by 3-6 Years of drug development experience, with emphasis on data preparation of Clinical Pharmacometrics
- Expert knowledge of data preparation and programming practices (CDISC, SDTM, ADaM) to support pharmacokinetics and Model-Based Drug Development
- Demonstrated ability to identify, develop and execute Pharmacometric data preparation and programming activities at the study level
- Varied programming languages (SAS, R, Pyhon)
- Knowledge of Browser programming skills (JSON, Java, Spring),
- Experience in early and late stage drug development
- Experience with relevant software and tools within the field of MBDD (e.g. SIMCYP, R, NONMEM, Monolix, Winbugs, Stan, Phoenix, PKS) (T)
- Knowledge in pharmacology, drug targets and core disease areas
- Good knowledge of global regulatory, compliance, processes, standards and issues specific to clinical pharmacology
- Scientific publishing in the field on pharmacometrics
- Quantitative/Scientific background (Statistics, Engineering, Biological Science)
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.