Expert in clinical trial methodology - Associate Director
Location: Cambridge, Gaithersburg or Gothenburg
Career Level E/F
At AstraZeneca we’re driving leading-edge approaches to drug development across many business areas – within Early Biometrics & Statistical Innovation (EB&SI) a data-centric focus is helping us work more efficiently and creatively to bring the right medicines to the right patients. Our biometrics and innovation teams use their expertise in statistics and programming to answer drug development objectives and reduce uncertainty in product development, driving better business decisions with quantitative reasoning.
You will sit within our Statistical Innovation group in EB&SI, which is a methodological hub for statistical design and analysis of clinical trials. Working as part of Data Science and AI, you’ll be able to access technology at the forefront of science in an innovative environment, where you will have the scope to develop creative statistical ideas and approaches, and to apply them in your work.
Main duties and responsibilities
Joining a team of statistical methodology experts, you will provide key input as you work to find solutions to problems at critical stages in the drug development cycle.
This is exciting and technically challenging work in a dynamic and constantly changing landscape. Your key focus will be on producing pragmatic solutions, often within a tight time scale where the emphasis will be to deliver first, then refine and develop your solutions thereafter.
You will contribute to, or lead capability build in more than one of the following statistical areas:
Methods to analyse data collected in real-time, Estimands, Missing Data, Subgroups and Biomarkers.
You will also provide expert consultancy on key issues for fellow statisticians working in our therapeutically aligned statistics groups, as well as medical scientists and other key roles across the business. This will involve leading and participating in strategic activities such as capability build projects, which can directly impact improvements to the way clinical trials are designed and analysed in AstraZeneca. As well as developing and implementing new methodology, interacting with external scientists and regulators, through publications, presentations and cross-industry collaborations. There will also be a focus proactively identify new areas where Statistical Innovation can add value, developing collaborative relationships with the external scientific/academic community.
- PhD in Statistics or a related discipline, followed by experience of independent academic research and/or clinical drug development
- Documented ability of delivering innovative statistical solutions in an applied environment (related to at least one of the following areas: Analysis of data collected in real-time (e.g. sensor data), Missing data, Subgroups and Biomarkers and Estimands
- Strong knowledge of programming in R and/or SAS
- High level of competence in global and cross-skilled collaborative working
- Track record of research and methodological development in Statistics, supported by scientific publications in first class statistical journals
- Desire to apply your scientific competence on practical problems, for the benefit of patients
- Knowledge / research experience in the development of statistical methodology related to the analysis and interpretation of safety data, observational studies, meta-analysis, Bayesian statistics, non-linear and mixed effect models.
- Broad awareness of statistical issues against the evolving scientific and regulatory landscape
In addition to be considered for appointment at the more senior level, the documented ability to deliver innovative statistical solutions should be in at least 2 of the areas listed above or be a recognised expert in one of these areas and an extensive publication record would be expected.
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.