Vertex is seeking a Principal Engineer to automate and streamline pre-clinical data pipelines and reporting processes to ensure the accuracy, consistency, and integrity of high impact, high visibility, and business-critical regulatory documents across research laboratories.
Requirements
- Understanding and experience of designing and implementing data and technology solutions in life sciences research and development
- Proficiency in data management and automation principles and methodologies
- Expertise in at least one or more programming languages including R and Python
- Expertise in interrogating large datasets via database access and query
- Knowledge of statistics
- Familiarity with data quality and reporting requirements in a regulated environment
- Proficiency in digital platforms and technologies, with the ability to evaluate and implement new tools and technologies
Responsibilities
- Identification and preparation of raw data files requested by regulatory agencies and support regulatory inspection readiness
- Generation of scientific study reports for post-file activities such as label expansion
- Assurance of quality control (QC) of critical data within data packages and documents used in Vertex research study reports
- Design, configure, develop and maintain automated solutions, tools and workflows for automated QC and report generation
- Regularly evaluate and optimize solutions, scripts, and workflows to enhance performance and scalability
- Ensure the accuracy, completeness, traceability and consistency of data across research business-critical documents (e.g. research study reports)
- Ensure generated reports meet formatting, regulatory, data integrity, and quality standards
Other
- Bachelor's degree in a relevant field such as Computer Science, Data Science, Engineering, or a related discipline or equivalent experience; advanced degree preferred
- 5+ years of experience in technical leadership, data management, or related roles within the biotechnology or pharmaceutical industry
- Strong collaboration and inter-personal skills
- Strong written and verbal communication skills, with the ability to present complex technical concepts to a variety of audiences
- Willingness to travel as needed (up to 10%) to support business objectives
