Senior Statistician 上海

月薪： 2-2.5万/月

该公司所有职位
  • 无工作经验
  • 招若干人
  • 11-09 发布

职位描述

职位描述： Position SummaryThe Senior Statistician provides statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product needs in Janssen. This position supports statistical aspects of business-critical and/or regulatory commitments. He/She abides by the Credo and practices J&J Leadership Imperatives for Individuals: Lead, Shape, Connect, and Deliver.Position Core Competencies, Responsibilities and AccountabilitiesExpertise: Demonstrates advanced data analytic expertise based on a foundation of statistical principles and a track record of applied experience. Is effective in the use of relevant computational tools for study, experiment, or trial research objectives. Applies high quality statistical methodology in assigned projects with demonstrated understanding of the disease/scientific/functional area and health authority acceptability. Ensures application of appropriate statistical methods and generation of accurate and reproducible results working independently or by providing specifications to statistical programming colleagues. Produces clear, concise, well-organized, and error-free computer programs and statistical reporting content.Quality and Compliance: Complies with organization and company standard operating procedures in timely fashion, such as training and project time accounting. Understands and aligns with relevant regulatory guidances. Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, project/compound statistical lead, and the Statistics Area Head. Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity.Drug Development: Acquires and demonstrates knowledge in pharmaceutical research and development strategies and execution. Assists in providing experimental design, modeling, analysis planning, analysis execution, interpretation, and statistical communications support. Is accountable for execution of individual project responsibilities, including: meetings with necessary project team members, reporting activities, exploratory analyses/graphics, and additional analyses to support publications for individual clinical trials/studies/projects. Provides critical input to the statistical lead or team in optimizing study or trial designs in line with study or trial objectives, and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge.Collaboration: Establishes and maintains effective and efficient interfaces and relationships with internal and external customers, with support of Statistics & Decision Sciences (SDS) management. Routinely contributes to area (e.g. discovery, translational, early development, late development) project meetings. Contributes positively to SDS team dynamics with a clear understanding of the SDS vision.Programming: Demonstrates full proficiency in SAS or R, as well as a working knowledge of other relevant computational tools as required.Process: Deep knowledge of data architecture, such as Data Standards. Recognizes the need and value of process standardization.External Engagement: Participates as a member of professional organizations, such as attending meetings sponsored by professional organizations.?Area Specific Core Competencies, Responsibilities and AccountabilitiesThese are additional to the above position core competencies, applicable to individuals according to their assigned area within Statistics & Decision Sciences.Discovery & TranslationalServes as initial consultation contact for new projects. Maintains and grows customer base, and builds loyal relationships with customers.Assumes independent, professional responsibility for all phases of a project request from beginning through completion, with minimal supervision as needed.Manages multiple projects.Documents projects in sufficient detail for reproducibility.Manufacturing & ToxicologyServes as initial consultation contact for new projects. Maintains and grows customer base, and builds loyal relationships with customers.Assumes independents, professional responsibility for all phases of a project request from beginning through completion, with minimal supervision as needed.Manages multiple projects.Documents projects in sufficient detail for reproducibility, including entry in project tracking systems and placement into shared repositories.Medical AffairsProvides statistical support to Medical Affairs studies and assumes responsibilities for planning, design and analysis of randomized clinical trials, observational studies and/or patient registries for post marketing commitments/requirements and reporting related activities. Applies sound statistical thinking and computational abilities in support of Medical Affairs goals & objectives.Contributes in the planning, design, conduct and analysis for clinical trials, observational studies and other types of clinical research projects including but not limited to post-hoc analyses, investigator initiated studies, publications, and HECOR/Epidemiology/Market Access support; Develops statistical analysis plans (SAPs) and data presentation specifications (DPSs); Provides statistical support for all LCM/regulatory-submission related activities; Interacts with other Medical Affairs functional groups (e.g., HECOR/Epidemiology, Market Access and publication teams); in close partnership with statistical lead, interacts with outside investigators (KOLs and vendors) in the preparation of scientific presentations and manuscripts and pursues implementation of robust statistical analyses in support of business-critical evidence generation; Explores and implements innovative statistical methods.?InterfacesInternal: Statistics & Decision Sciences, Clinical Pharmacology & Pharmacometrics, Clinical Teams (or Equivalent) and associated working groups, Statistical Programming, Data Management, Medical Writing, Leaders and Scientists within Therapeutic and Functional Areas, R&D Operations, Medical Affairs, Manufacturing, Safety, Regulatory Affairs, Quality, Human Resources, Information Technology, Finance.External: Contracted Partners, Academia, Professional Societies, Private and Public Consortia.Education and Experience RequirementsPh.D. in Statistics or related field with minimum 0-2 years relevant experience, or Master’s in Statistics or related field with commensurate years of relevant experience.Basic knowledge of SAS or R programming.Good written, oral, and interpersonal communication skills. 职能类别： 生物工程/生物制药

联系方式

虹桥路355号城开国际大厦

公司信息

公司简介(中文) 恢复为 “成立于1985年的西安杨森制药有限公司（“西安杨森”）是中国最大的合资制药企业之一，也是中国改革开放以来进入中国的最早一批制药公司之一，其总部位于北京的中央商业区。西安杨森是强生公司的一员。从创立之初，西安杨森就致力于引进和生产许多创新产品和高质量产品。西安杨森一直致力于投资未来，计划增加在生物制品、心脏病学、风湿病学和泌尿科学领域的新系列产品。西安杨森致力于利用这些新药改善中国患者的医疗保健状况。 本着公司信条和关爱精神，西安杨森一直是活跃的企业公民，在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如，西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”，旨在鼓励医药学领域的工作者不断创新。在过去的17年中，共计305名杰出医药学工作者在45个专业领域获得了该奖项，他们在科研领域做出了大量有价值的创新。 此外，西安杨森也被誉为培养制药行业人才的摇篮。1999年，西安杨森被财富杂志（中文版）评选为“中国最受敬仰的十大外资企业之一”。2005年，西安杨森被中国中央电视台评选为“***雇主”，并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。 目前西安杨森所有的招聘信息仅通过前程无忧，智联招聘和猎聘网进行发布，任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害，请务必通过正规渠道投递简历。 2013年，强生在西安高新区投资兴建强生全球供应链先进的生产基地，该项目建设目前已正式启动。新生产基地占地267,000平方米，将取代西安杨森在西安新城区现有的生产基地，成为强生供应链在亚洲的创新枢纽，从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系，并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。

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