Senior Statistical Programming Lead

在 Johnson & Johnson，我们相信健康就是一切。 我们在医疗创新方面的实力使我们能够建立一个能够预防，治疗和治愈复杂疾病的世界,在这个世界中,治疗更智能，侵入性更低,并且解决方案是个性化的。 凭借我们在创新医学和医疗技术方面的专业知识,我们处于独特的地位,能够在当今的全套医疗保健解决方案中进行创新,以实现未来的突破,并对人类的健康产生深远的影响。 如需了解更多信息，请访问jnj.com

在我们的信条指引下，强生公司对全球范围内与我们共事的员工负有责任。我们提供一个包容的工作环境，在这里每个人都被视为独立的个体。在强生，我们尊重员工的多样性和尊严，并认可他们的价值。

工作职能：Data Analytics & Computational Sciences

作业子功能：Biostatistics

职位类别：Scientific/Technology

所有职位发布位置：Shanghai, China

职位描述：
Position Summary:

The Senior Programming Lead is an experienced programmer with an advanced knowledge of programming languages, has expertise in industry standards, complex data structures and programming methods, having the technical capabilities in leading trial activities in accordance with departmental processes and procedures.

This role is responsible for providing expertise, planning and oversight of one or more programming trial activities of moderate to high complexity. The role makes decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables, and provides leadership, direction, and technical guidance to programming teams.

This role develops cross-functional working relationship with stakeholders to shape processes and practices and contributes expertise to Delivery Unit or departmental innovation and process improvement projects.

The Senior Programming Lead position combines the expertise and responsibilities in their respective programming roles, making them an asset to IDAR’s C&SP activities.

Principal Responsibilities:

Responsible for planning, programming strategy, coordination, oversight, and execution of team activities following J&J IM and industry standards for one or more clinical trials or projects.

Designs and develops programs in support of complex clinical data analysis and reporting activities.

Supports submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages and reviewer’s guides.

Provides technical and project-specific guidance to team members, ensuring high-quality, efficiency and on-time deliverables in compliance with departmental processes and procedures. Ensures use of latest standards and deployment of current technologies.

Collaborates effectively with cross-functional team, counterparts, vendors to achieve project goals and manages escalations independently.

Supports submission activities while ensuring the highest level of consistency and quality across trials by creating efficiencies in clinical data flow and implementing metadata-driven approaches.

As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality.

May play the role of a Delivery Unit/Disease Area Expert contributing to standards strategy and providing expertise for a specific Delivery Unit/Disease area across value streams in support of clinical programs including submissions.

Contributes to departmental innovation and process improvement projects by supporting and/or leading developing and implementing processes, systems, and tool improvement initiatives.

Principal Relationships:

This role reports into a people manager position within the Delivery unit and is accountable to the Portfolio Lead for assigned activities and responsibilities.

Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations.

Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources.

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, mathematics, data science/analytics/data engineering, public health, or other relevant scientific field (or equivalent theoretical/technical depth).

Experience and Skills Required:

Approx. 4+ years programming and or clinical data management experience with increasing responsibility preferably in pharmaceutical/clinical trial environment.

Knowledge of programming practices (including tools and processes).

Knowledge of data structures and relevant programming languages for data manipulation/statistical analysis and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required.

Expert CDISC Standards knowledge.

Experience in planning and coordinating programming activities and leading teams.

Experience working with cross functional stakeholders and teams.

Experience in vendor management oversight.

Project management skills and knowledge of team management principles.

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

Demonstrated written and verbal communication skills.

Required Skills:

Preferred Skills:
报告撰写, 标准操作程序 (SOP), 高级分析, 精通技术, 良好临床实践 (GCP), 临床试验, 批判性思维, 生物统计学, 数据隐私标准, 数据知识, 数据质量, 数字流畅性, 统计, 统计分析系统 (SAS) 编程, 系统开发, 协作, 质量保证 (QA), 咨询