Associate Director, Clinical Data Programmer

Role Summary

The Clinical Data Management team is seeking an Associate Director, Clinical Data Programmer who will provide hands-on data management and programming leadership to develop, maintain, and validate the clinical database and to run programs that access, visualize, and report clinical trial data in accordance with clinical plans, ICH guidelines, and applicable regulatory requirements. As the Associate Director of Clinical Data Programming, you will program in appropriate languages to create textual and graphic displays that facilitate data cleaning and review.

Responsibilities

• Lead the study-specific design, development, and validation of study clinical data capture systems, ensuring data integrity, CDISC compliance and CRO oversight.
• Support leading data management activities (e.g., DMP creation, CRF creation, edit checks creation, database lock), assisting with database setup, conduct and closeout phases.
• Perform UAT of systems and ensure appropriate plans and documentation are in place.
• Lead the development of SAS macros, data listings, summary tables and visualizations for supporting periodic and ad hoc data review.
• Manage external vendor compliance and quality checks.
• Support Clinical Operations, Biostatistics and Data Management by providing data insight and solving technical data challenges.
• Ensure databases adhere to SOPs, 21 CFR Part 11, ICH-GCP and CDISC Standards (CDASH/SDTM).
• Act as a subject matter expert in leading technical initiatives and data management.

Qualifications

• 8+ years of experience in clinical data management.
• Extensive experience with clinical data systems (particularly Medidata Rave) and languages like SAS, R, or Python.
• Proven experience in clinical trial programming and database management.
• Knowledge of Clinical Data Standards such as CDISC CDASH and SDTM.
• Experience creating advanced interactive data visualizations from raw data using multiple languages and applications such as SAS, R, Python, RShiny, Power BI, Tableau, and Spotfire.
• Ability to manage multiple projects simultaneously, manage conflicting priorities, and adapt to changing priorities.
• Excellent written and verbal communication skills and strong organizational and documentation skills.
• Provide strong support to Data Management.

Education

• Bachelor’s degree or higher in Life Science or related discipline.

Skills

• Programming languages: SAS, R, Python; SAS macros.
• Clinical data systems: Medidata Rave; data capture and database management.
• CDISC standards: CDASH, SDTM; SOPs; 21 CFR Part 11; ICH-GCP.
• Data visualization: SAS, RShiny, Power BI, Tableau, Spotfire; data listings; figure/table generation.
• UAT, data cleaning, data quality assurance.
• Cross-functional collaboration and vendor management.

Additional Requirements

• Remote work within the United States; limited travel may be required; travel to the Cambridge, MA area several times per year and attendance at company-related events as needed.
• Must have a work setup at a remote location that supports privacy, reliable internet, and video conferencing capabilities.