・Acts as the lead biostatistician for one or more clinical studies within a clinical program or across multiple clinical programs.
・Gives input into the study design, efficacy and safety parameters and the planned statistical analyses. Performs simulations to support choice of study design, decision rules and the sample size. Participates in protocol development if this is not delegated to an external partner biostatistician. Reviews and approves the protocol prepared by the external partner biostatistician.
・Supports or overseas external partner biostatistical support for all statistical operational aspects of the clinical trial, covering trial set up, trial delivery and the readout of results. This includes input into randomization specifications, statistical analysis plans, interim analyses, safety reviews and final analyses.
・Ensures that scientific questions for research objectives are defined clearly and that data collection, statistical methods and analyses are optimally designed to provide statistical evidence to answer those questions in alignment with project objectives.
・Provides insight on the risk associated to a decision.
・Ensure non-clinical assays/analysis for compounds in development are fit for purpose and coordinate, the planning of these statistical deliverables in alignment with the project’s development plan
・Lead one or more biomarker, ‘omics or big data projects, offering expert statistical input across all stages of analysis, from feasibility and optimal study design to dissemination of results.
・Oversees the development and maintenance of advance predictive models to improve decision-making for clinical studies, clinical strategy, operational efficiency and patient experience.
・B.A. / Ph.D or Master
・Specific skills/competences (Include specific skills and knowledge necessary to meet the objectives of the role)
・Able to serve as a senior statistical expert in SSI and across functions.
・Experience with a variety of relevant statistical methodologies, including Bayesian approaches.
・Excellent communication and presentation skills.
・Good knowledge of SAS and/or R programming.
・Excellent knowledge in visualization and simulation techniques.
・Excellent written and verbal communication skills in English.
【就業時間】 フレックスタイム制 （フレキシブルタイム 6:00-22:00、コアタイム無し、一日当たりの所定労働時間は 7 時間 30 分）