<職務内容>
The Project statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.
[Clinical Project Statistician]
Provide strong statistical leadership in the process of drug development.
[Real World Analytics Project Statistician]
Provide input and statistical leadership for post launch activities including Health technology assessment (HTA), real world evidence (RWE) research, post-market safety studies, medical affairs publications to maximize the value of our products in collaboration with cross-functional and cross-regional partners.
主な職責/Primary responsibilities
Statistical Trial Design and Analysis
[Clinical Project Statistician]
・Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.
・Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created.
・Collaborate with data management in the planning and implementation of data quality assurance plans.
・Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
・Participate in peer-review work products from other statistical colleagues.
[Real World Analytics Project Statistician]
・Lead statistical activities with the development of protocols, analysis plans and analysis execution and interpretation for RWE research and post-market safety studies.
・Provide technical statistical leadership for network meta-analysis/indirect comparisons, economic modelling and dossier development for Health technology assessment (HTA).
・Ensures high quality statistical support for projects through the oversight of external suppliers and provides input into outsourcing strategy and processes.
・Influences cross-functional team members regarding appropriate research method.
Communication of Results and Inferences
・Collaborate with team members to write reports and communicate results.
・Assist with, or be responsible for, communicating study results via regulatory submissions,
manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
・Respond to regulatory queries and to interact with regulators.
Therapeutic Area Knowledge
・Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
Regulatory Compliance
・Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training
■休日：完全週休二日制, 年末年始
