Associate Director, Clinical Data Engineer (CDE)

Role Summary

Associate Director, Clinical Data Engineer (CDE) leads enterprise-level data extraction, transformation, and pipeline construction to support clinical trial data management and analyses. They ensure data conform to common data models and enable ingestion from multiple sources (e.g., EDC, IRT, ePRO/eCOA) with data lake readiness and reusable code libraries. The role provides technical leadership across teams to deliver timely, high-quality data for regulatory submissions and secondary use. Location: Massachusetts - Virtual.

Responsibilities

• Ability to manage teams and timelines across multiple functional areas and platforms. Mentor and guide other team members
• Advanced knowledge and ability to liaise with outside groups in a matrix environment
• Building required infrastructure for optimal data extraction, transformation and loading of data using cloud technologies like AWS, Azure
• Develop end to end processes on the enterprise level for use by the clinical data configuration specialist to prepare data extraction and transformations of raw data quickly and efficiently from various sources at the study level
• Manage timelines, deliverables and communications across organization
• Develop and maintain, tools, libraries, and reusable templates of data pipelines and standards for study level consumption by data configuration specialist
• Collaborate with various vendors and cross functional teams to build and align on data transfer specification and ensure a streamlined process of data integration
• Develop organizational knowledge of key data sources, systems and be a valuable resource to people in the company on how to best integrate data to pursue company objectives.
• Provides technical leadership on various aspects of clinical data flow including assisting with the definition, build, and validation of application program interfaces (APIs), data streams, data staging to various systems for data extraction and integration
• Coordinates with data base builders, clinical data configuration specialists and data management (DM) programmers ensuring accuracy of data integration per SOPs
• Provide technical support / consultancy and end-user support, work with Information Technology (IT) in troubleshooting, reporting, and resolving system issues
• Efficiently prepare and process large datasets for various end users for downstream consumption
• Understand end to end requirements for stakeholders and contribute to process and conventions for clinical data ingestion and data transfer agreements
• Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations
• Performs clinical data engineering tasks according to applicable SOPs (standard operating procedures) and processes

Qualifications

• BS with 9+ years’ experience. Minimum of 5 years’ experience in data engineering, building data pipelines to manage heterogenous data ingestions or similar in data integration across multiple sources including collected data.
• Experience with Python/R, SQL, NoSQL
• Cloud experience (i.e. AWS, AZURE or GCP)
• Experience with GitLab, GitHub
• Experience deploying data pipelines in the cloud
• Experience with Apache Spark
• Experience setting up data warehouses, data lakes (e.g., Snowflake, Amazon RedShift)
• Experience setting up ELT and ETL
• Experience with unstructured data processing and transformation
• Experience developing and maintaining data pipelines for large amounts of data efficiently
• Must understand database concepts. Knowledge of XML, JSON, APIs
• Demonstrated ability to lead junior Data engineers and resolve problems independently and collaboratively
• Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands
• Ability to work independently, take initiative and complete tasks to deadlines
• Supervision: able to supervise and collaborate with all levels of employees
• License/Certifications: Preferred to have AWS or R or Python certification

Education

• Bachelor's degree in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job.

Skills

• Strong attention to detail, and organizational skills
• Strong Project leadership and people skills
• Strong understanding of end-to-end processes for data collection, extraction and analysis needs by end users
• Strong ability to communicate with cross functional stakeholders
• Strong ability to develop technical specifications based on communication from stakeholders
• Quick learner and comfortable asking questions, learning new technologies and systems
• Experience creating custom functions Python/R
• Cloud computing (AWS, Snowflakes, Databricks)
• Ability to visualize large datasets
• R shiny/Python App experience a plus
• Experience developing R shiny and Python apps