南京招聘

职位描述：
General Summary
Principal Statistical Programmers provide leadership and high‐level expertise to the statistical Programming group. They are responsible for coordinating and mentoring statistical programmers across multiple project teams, along with performing resource allocation and timeline coordination. Principal Statistical Programmers lead initiatives to develop standards, processes and procedures. In addition Principal Statistical Programmers are responsible for the extraction of data from various sources, and combining these data into submission‐ready datasets, and for the creation of derived datasets, tables, figures and listings that support clinical study reports and integrated summaries. The work requires an understanding of the theories and methodologies behind the tabulation, integration, analysis, reporting, and integration of clinical data, along with the ability to apply SAS® programming language to produce clinical data summaries.
Accountabilities
? Programs tabulation datasets and statistical analyses (via analysis datasets, tables, figures, listings, etc.) using an appropriate statistical analysis systems (i.e. SAS®).
? Ensures the accuracy and consistency of data flow from case report forms (CRFs) and database definitions, through to and specifications for tabulation datasets and analysis datasets.
? Performs qualify review of tabulation datasets, analysis datasets and TFL programs developed by other programmers and biostatisticians.
? Verified that all tabulation programs/statistical analysis system programs and associated documentation are archived following the creation of final datasets and outputs.
? Develops new processes and makes sure all process improvements are implemented.
? Takes a lead role in the review of statistical analysis plan and provides essential feedback.
? Collaborated with other team members to develop quality reports, publications and submission.
? Maintains libraries of documented and validated programs, macros, and procedures which can be reused to aid in department efficiency.
? Serves as the chief mentor to other programmers.
? Demonstrates a working knowledge of industry metadata submission requirements.
? Contributes to departmental initiatives and acts as an SME on technical subjects as applicable.
Job Factors
Applied Knowledge & Skills
? Demonstrates expertise knowledge of computer programming, statistical analysis systems (SAS), and other procedural languages.
? Fully understands clinical informatics procedures, workflows and software systems.
? Displays ability to manage extremely large datasets for statistical analysis and mathematical model creation.
? Exhibits excellent written and oral communication skills.
? Demonstrates expert knowledge and understanding of tabulation and analysis data structure standards (SDTM, ADaM).
? Applies advanced leadership skills in the coordination of statistical programming projects.
Problem solving
? Problems are differing but related.
? Undertakes analysis and investigation to identify issue and define the problem.
? Many problems require sophisticated analytical or problem solving techniques to define and identify cause.
? Requires evaluation, interpretation and judgment to select the right course of action.
? Anticipates future issues.
Impact
? Contributes to the achievement of goals through personal effort and influence over others in department.
? Impact is limited to achievement of short-medium term achievement goals.



Minimum Qualifications
Education
? Bachelor degree in a quantitative or scientific field.
Experience
? At least 7 years of statistical programming experience.
Preferred Education and/or Experience
? Advanced degree preferred. 举报 分享

康德弘翼（WuXi Clinical），是药明康德（WuXi AppTec）的一家全资子公司。始终致力为全球客户提供全方位的临床研究服务，包括药品、生物制品、医疗器械、体外诊断试剂等医药产品。从I期临床研究到最终申报注册，通过严格的质量控制体系和专业团队的丰富经验，帮助创新性，突破性医药产品尽快上市和造福患者。

康德弘翼立足中国，面向世界，以上海总部为中心，辐射全球制药公司、生物技术公司以及医疗器械公司。目前，公司实行中美联合运营，人员规模达850人，覆盖中美两地，全国30多个主要城市，在上海、北京、广州、武汉、成都、长沙、西安、沈阳和美国奥斯汀、圣地亚哥10个城市均设有办公室。公司团队与各研究中心建立了良好的合作关系，始终保持着紧密的业务交流，保证了项目能高效、高质地完成。

随着业务能力的不断提升，我们已将业务范围成功扩展到美国、欧盟和亚太地区的部分国家。2018年7月，药明康德成功收购位于德克萨斯州的一家美国临床研究机构并实现中美联合运营，2019年5月，再一次收购了位于圣地亚哥的临床研究服务公司Pharmapace，这让WuXi Clinical的规模再一次得到扩大，进一步完善和增强了我们全球一体化研发服务平台的综合实力，帮助全球创新合作伙伴更好、更快地开发医药产品。