Associate Director Biostatistics, Late Oncology
At AstraZeneca we are constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as together we explore synergies between small and large molecules.
AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Those who join AstraZeneca feel a sense of ownership about their future. They thrive with a recognized leader in the industry. AstraZeneca is an agile, fast-moving and emerging industry leader in oncology. We are a nimble organization that values smart risk-takers.
With AstraZeneca, you will be applying a creative approach to science while being at the forefront of a strong and rich pipeline of cutting-edge medicines. Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities.
Our Oncology Pipeline
Our robust pipeline includes investigational therapies in varied stages of clinical development, from recently approved products to earlier-stage molecules in clinical trials. We aspire to transform the lives of cancer patients, working to eliminate cancer as a cause of death in the future.
We have an exciting opportunity for Associate Director Biostatistics, Late Oncology located in our Gaithersburg MD or Waltham MA Office.
In this role you will provide statistical expertise for complex design and interpretation of clinical studies, regulatory submissions and commercialization. You will also act as a coach/guide for less experienced statisticians in the production of analysis, supporting graphics and analysis tables for CSRs, GMA studies or publications.
You will also:
- Analyze internal and external information to inform design decisions and the development of decision criteria
- Develop a Statistical Analysis plan for complex studies and/or project deliveries
- Provide support to the complex study analysis, regulatory submissions including specification of overview documents and response to regulatory questions
- Contribute to the regulatory submissions including specification of overview documents and response to regulatory questions
- Identify opportunities for the application of modelling and simulation to improve study design
- Identify and apply statistical methodology to improve the process and delivery activities
- Perform ad hoc and exploratory data analyses
- Contribute to the development of best practice to improve quality, efficiency and effectiveness
- Minimum MSc in Statistics, Biostatistics, or Mathematics (containing a substantial statistical component)
- Knowledge of the technical and regulatory requirements related to the role and able to guide others on these
- Experience in drug development, study design, and data analysis and interpretation
- Excellent communication skills and ability to build strong relationships
- Excellent collaboration skills required – the energy to work across global & functional boundaries, both internally and externally
- Project management skills
- Ability to apply statistical expertise to complex problems, problem solving and quality focus
- Desirable Qualifications
- Ph.D. in Statistics, Biostatistics or Mathematics (containing a substantial statistical component).
- Experience in Oncology product development
- Coaching skills
- Experience in commercial or early development support work
- Expert statistical programming skills (SAS and R)
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.