Report to Statistical Sciences Group head or an associate director or above. Function independently as a primary statistician for multiple projects to provide support for nonclinical research and development programs including pre-clinical and early-clinical studies, biomarkers and ‘omics, real-world evidence, pharmacovigilance, assay and process development, quality control, and manufacturing. Apply statistical principles and techniques to provide solutions to a wide range of difficult problems in the drug research and development environment. Contribute to development of objectives and timelines associated with specific projects. Provide high level of support for regulatory filings. Demonstrate technical excellence in certain statistical areas through both novel statistical research and application. Build effective relationships with peers and management in biostatistics and other departments. Participate in development of departmental process and infrastructure, as well as cross-functional committee activities.
Major Duties and Responsibilities:
Collaborate with various scientists in the design, analysis and reporting of laboratory and early clinical experiments
Responsible for determining strategy and delivering results as a core member of scientific teams. Ensure rigorous approaches are taken to ensure good scientific practices are followed: excellent statistical methods utilized and documented in protocols, analysis plans and manuscripts
Bring innovative statistical thinking and methods to help drive and enhance quantitative drug discovery and development. Interact with and influence internal and external experts
Provide high level of support for regulatory submissions, such as IND and BLA, including meetings with regulatory agents and addressing regulatory requests
Design and deliver targeted statistical training for scientists
MS or PhD in statistics or other related field with high statistical content
Minimum of PhD with 4 years or MS with 6 years of industry experience in drug research and development environment or related industry
Complete understanding and wide application of statistical methods and applications
Experience in regulatory interactions and BLA/IND development and submission
Effective oral and written communication and interpersonal skills
Demonstrated ability to work effectively as part of a team
Excellent programming skills in one or more of R, SAS, Python, and Stan/BUGS/JAGS
Expert experience with methods from design of experiment, Bayesian statistics, predictive modeling including deep learning, linear and nonlinear mixed modeling, and/or epidemiology
Require taking on multiple projects with varying priorities. Require ability to recognize statistical issues that may critically affect study outcomes and relay the problems to appropriate level of management in a timely manner.
Limited supervision by Statistical Sciences Group head or an associate director or above.
May mentor or supervise student interns or junior statisticians
At MedImmune, the worldwide biologics R&D arm of AstraZeneca, we do cutting-edge science you won’t find everywhere. In a way you won’t find anywhere. As the frontiers of science are changing, we’re setting the pace – pioneering innovative research and exploring novel pathways across Oncology, Respiratory, Cardiovascular & Metabolic Diseases, Infections and Vaccines.
You’ll be part of a broad and exciting pipeline. Working with the best minds and the best facilities, with fewer boundaries than you might be used to. You’ll enjoy the open collaboration of a biotech and the flexibility associated with academia. So if you believe in following the science, improving patient outcomes, taking ownership of innovation and breaking new ground, join us.
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