Lead Software and Clinical Data Engineer

The Lead Software and Clinical Data Engineer in Data Processing Solutions acts as an expert in clinical data processing technologies to guarantee support required by the Global Development (GD) organization. As a member of the Data Processing Solution team, they will develop in-depth knowledge in clinical data management and programming technologies and take an ownership for projects to either build new or improve existing solutions for the clinical study teams.

This role will be responsible for designing and developing digital tools and processes to support clinical trial data integrations, transformations and analyses as well as clinical data standards management. They will also support a clinical trail data flow from acquisition systems through landscape of all downstream systems.

They will collaborate with data managers, clinical and statistical programmers, clinical teams, biostatisticians, medical writers, technical specialists, and external vendors. This position has no direct reports, however it may provide direction to external vendors and contractors.

This role will require building strong internal and external partnerships and will collaborate daily with other team members located in US, Europe and Asia. It uniquely combines technical and programming skills with a broad exposure to clinical data processing as well as collaboration with multiple functions in clinical development.

The following are examples of the solutions, which may be part of the supported portfolio:

• Data Management Environment (DME) platform;
• Statistical Programming Environment (SCE) platform;
• SAAS based solutions tailored to the life sciences industry;
• Customized web platforms to automate clinical data management activities like clinical standards library management, clinical study specification setup and clinical data validation;
• Data conversion frameworks and tooling to translate raw data into datasets for regulatory submissions and for analysis and for consumption by various downstream applications

Key Responsibilities :

• Develop digital tools, programs, and processes for use by global user community within Global Development
• Provide technical lead to the deployment of new solutions
• Provide technical support, mentorship, and or coaching in a domain of their expertise
• Build and operate infrastructure, toolset, and deployment pipelines within platforms supported by Data Processing Solutions team
• Develop scalable and robust code in R or Python
• Write code that is high quality, well documented, efficient and is easy to maintain
• Drive testing and deployment of software solutions, including implementing of automated testing to ensure solution quality
• Improve operational efficiency by developing automation tools and scripts (e.g. CI/CD automation)
• Provide ongoing solution support, incl. incident and problem management (L2+), root cause analysis, and request fulfilment
• Identify, participate or lead in process, system, and tool improvement initiatives
• Ensure compliance with regulatory, security and other audit requirements at all times
• Conducts requirements collecting and analysis
• Share expertise to support the clinical data delivery and analysis teams and Clinical Research Organizations (CROs) by coordinating trainings, Question and Answers sessions, and organizing direct support when needed