职位描述
职位描述: Job Title: Senior Biostatistician or BiostatisticianJob Purpose:The Senior Biometrician is responsible and accountable for leading and delivering statis-tical analytic solutions relevant to the scientific research objectives for multiple Phase I-IV clinical trials at a trial level by executing RAPs, ensuring high quality and timely pro-duction of statistical reporting deliverables (tables, listings and graphs), supporting deci-sion making at the CTT/GCT and working together with other statisticians and the pro-grammer.Major Activities:1. Support the statistical team in protocol writing as required, optimizing clinical trial designs in line with trial objectives, and supporting scenarios simulations and sample size calculations based on relevant technical and disease knowledge.2. Responsible and accountable for transcribing MAP aligned RAPs into computational solutions for the statistical programmer to implement (specifications of derived variables, specification and development of statistical computing solutions for inferential statistical analyses, tables and listings templates, and modern statistical graphics for the FIR and CSR) of Phase I-IV clinical trials.3. Responsible and accountable for multiple studies RAP execution including the RAP meetings with the necessary CTT members, reporting activities, exploratory analyses/ graphics and additional analyses to support publications for individual clinical trials.4. Ensure that documents, specifications, programs/macros are consistent and comply with CSU/project/company standards/processes and provide operational input into VAPs, specifications of analysis datasets, listings, tables and figures, CSR for Phase I-IV clinical trials ensuring that consistent practices across multiple studies is kept5. Ensure to deliver agreed timelines and high quality for statistical deliverables and processes, and ensure audit-readiness.6. Establish and maintain efficient interfaces with internal and external customers with support of IIS management.7. Support statistical research by providing advice and solutions on computational aspects of the problem.8. Provide statistical analysis solutions when exploratory analyses are required.9. Attend CTT/GCT meetings to help facilitate decision making during design, conduct and reporting of clinical results10. Contribute to change initiatives11. Contribute to project level activitiesIdeal Background:Education:(in Statistics or equivalent) with 2+ years relevantwork experience or PhD (in Statistics or equivalent)with no work experienceExperience/Professional Requirement:1. Working knowledge of/experience with SAS/ R/Splus or any other business or research analyticsoftware with an expertise in at least one software.2. Statistical and numerical knowledge and expertisein analytic aspects.3. Good knowledge of data architecture4. Excellent interpersonal and communication skills 职能类别: 临床数据分析员 关键字: 统计师 SAS