北京招聘

Position Summary:

The Clinical Programmer is a clinical trial programmer with basic knowledge in data structures, programming languages, and/or report solutions who supports clinical programming trial activities and/or teams in accordance with departmental processes and procedures.

The position is responsible for review of project specification and documentation, verification of internal data models and/or CDISC submission ready SDTM tabulation packages (aCRF, define.xml, cSDRG, etc.).  Develop, verification and documentation of edit check programs, listings and report solutions to aid in monitoring of safety risk, compliance and ensures quality data review.

This position is a member of the clinical programming team and is capable of supporting programming activities with guidance and may contribute to departmental innovation and process improvements.

May perform role to support reporting solutions aggregating clinical data sources into custom data and reports to monitor safety, risk and compliance. 

Principal Responsibilities:

·         Accountable for one or more clinical programming trial activities of low complexity, scope and/or criticality.

·         Performs review and input into, project requirements and documentation. 

·         Ensures latest standards are being utilized, current technologies are deployed.

·         Review specifications for mapping internal data review model for fit for purpose reporting consumption and/or submission ready CDISC SDTM.

·         Support internal data model for fit for purpose reporting consumption and/or submission ready CDISC SDTM packages for health authority submissions.  Provide programming support or oversight of quality review checks and reports for use by team members and consumers of data.

·         May perform support role that programmatically aggregates clinical data sources into custom data model for fit for purpose consumption study specific report solutions performing appropriate quality control and verification in support of assigned reporting activities.

·         Collaborates effectively with team and cross-functional counterparts and vendors to achieve project goals.

·         May contribute to departmental innovation and process improvement projects.

·         Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position.

 

 

Responsibilities for others:

Principal Relationships:

·         Reports into people manager position within the functional area.  Accountable to the Portfolio Lead, Clinical Programming and/or Associate Director, Portfolio Lead for assigned activities and responsibilities.

·         Functional contacts within organization include but are not limited to; Data Management, Clinical Data Standards and Transparency, Process Sourcing & Compliance, Statistical Programming & Analysis, Risk Management Central Monitoring, IDAR Therapeutic Area Leaders.

·         Functional contacts within Janssen (as collaborator or peer) include but are not limited to Global Trial Lead or equivalent, EBIS, Quantitative Sciences, Biostatisticians, Regulatory, Clinical BRQC-QP&S.

·         External contacts include but are not limited to, external partners, CRO management and vendor liaisons, industry peers and working groups.

 

Education and Experience Requirements:

·         Bachelor’s degree or higher and/or equivalent in computer science, data science/data engineering, mathematics or another relevant scientific field (or equivalent theoretical/technical depth).

·         Preferred Experience: Relevant programming experience, preferably in pharmaceutical/clinical R&D environment.

·         Knowledge of data structures and relevant programming languages for data manipulation and reporting.  May include SAS, R, Python, etc. Knowledge of SAS is preferred.

·         Demonstrated written and verbal communications skills.

·         Experience working in a team environment preferred.

·         Demonstrated written and verbal communications skills.

·         Basic knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.

Work Location

Beijing,Shanghai

强生是全球具综合性、业务分布范围广的医疗保健企业，业务涉及消费品、制药、医疗器材三大领域，1985年在华创立了***家合资企业。强生遵循企业信条的价值观，致力于践行“关爱全世界,关注每个人”的健康愿景，以领先的科技研发创造创新的理念、产品和服务，为改善人类健康和福祉而不懈努力。每天，强生遍布世界各地的员工，与他们的合作方一起，为全球消费者和病患带来更健康、更快乐、更长寿的生活。
强生于1985年在华创立了***家合资企业。 多年来，强生不断发挥行业领军作用，以创新、高质量的产品和服务，为中国亿万家庭带来健康。如今，强生在中国的业务涉及消费品、制药、医疗器材三大领域，在北京、上海、广州、苏州、西安等90多个城市，拥有员工总数近10,000人。强生在西安高新技术产业开发区投资兴建先进的大型生产基地，以更好地服务中国和亚太地区其他国家。
强生是***在中国成功实现“端到端”研发模式的跨国企业；并通过实现从早期研发到临床应用，致力于加速中国创新产品的研发，促进中国创新型经济的发展。强生的三大业务领域在中国均设有研发机构, 并在上海建立了强生亚太创新中心，将源自于中国和亚太区域的创新成果推向国际市场。
该创新中心是强生深化外部合作战略的主要窗口。强生将密切与创新企业、学术和科研机构，以及优秀人才的合作，通过提供资金、专业知识和技术，共同将雏形创新转化为医学临床应用的成果，强生并在中国建立全球肺癌研究中心，以满足中国及国际市场的需求，造福病患。
强生心系中国的发展和进步，致力于成为优秀的企业公民。强生积极参与各类重大活动，助力中国的社会经济发展， 并荣幸的成为2008年北京奥运会及残奥会和2010年上海世博会美国馆的全球合作伙伴。
为加强对中国市场的承诺，强生于近期部署了中国发展新战略。强生将融汇全球的资源、凝聚在华的核心业务能力，更加稳健的迈开公司积极创新、完美执行和锐意领先的步伐，为中国创造更多价值。
强生多次荣获《巴伦周刊》“全球最受尊敬企业”的荣誉，充分体现了强生始终以实际行动改善人类健康福祉的不变理念。
2017年，强生连续第33年入选美国《财富》杂志发布的全球最受赞赏企业排行榜，位列总榜第13名，居全球制药行业榜首。