Associate Director Clinical Informatics

Job Title: Associate Director Clinical Informatics

Job Number: 32276

Location: Boston, MA

Job Description

The successful candidate will report to the Head of Development Operations and will support the GxP strategy for clinical development data flow and analytics infrastructure across the clinical development portfolio.  The role will work with cross functional stakeholders to lay the foundation of data acquisition, storage, and analysis as we continue to move our compounds into the clinic and through the drug development cycle. Understanding best practices for clinical data standardization processes and management are critical to support the clinical data flow from initial trial data collection to final data submission, and to be able to leverage the data across data sources and third parties.

Responsibilities

• Partner with clinical data management and key functional stakeholders to implement the data and analytics strategy.
• Collaborate with key clinical and translational stakeholders to understand their business needs to develop user requirements, business rules and processes related to clinical data flow.
• Drive data process flow standardization in the process of clinical data management and implement fit for purpose data policy and solutions.
• Collaborate with computational genomic, research informatics and clinical data science team members to develop analytics applications ensuring secure and controlled clinical data management using AL/ML and cloud based technology.

Required Skills

• Bachelor’s degree in Computer Science or equivalent required. Advanced degree preferred.
• 8 years of experience in clinical informatics or clinical data/statistical programming.
• Proven experience with clinical trial data flow, process, and standardization.
• Solid knowledge on a large span of industry data standards: CDISC, STDM, ADaM, OMOP, BRIDG, etc.
• Working experience with SAS, SPOTFIRE
• Proven experience with data visualization best practices
• Experience with Computerized System Validation and global regulatory requirements for data privacy and protection (GDPR).
• Strong experience with external vendor integration (CRO, specialty labs, imaging labs etc.) and vendor technology management.
• You can identify opportunities to use data as an asset to drive operations efficiency and generate novel insights to accelerate processes.
• Solid understanding of SaaS, cloud, and AI technologies in a GxP environment.
• Strong collaboration and communication skills