Associate Director, Clinical Data Programmer

Responsibilities:
- Lead the study-specific design, development, and validation of study clinical data capture systems, ensuring data integrity, CDISC compliance, and CRO oversight.
- Support data management activities (DMP creation, CRF creation, edit checks creation, database lock) across database setup, conduct, and closeout phases.
- Perform UAT of systems and ensure appropriate plans and documentation are in place.
- Lead development of SAS macros, data listings, summary tables, and visualizations for 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.

Required Qualifications:
- Bachelor’s degree or higher in Life Science or related discipline.
- 8+ years of experience in clinical data management.
- Extensive experience with clinical data systems (particularly Medidata Rave) and SAS, R, or Python.
- Proven experience in clinical trial programming and database management.
- Knowledge of CDISC standards (CDASH and SDTM).
- Experience creating interactive data visualizations from raw data using SAS, R, Python, RShiny, Power BI, Tableau, Spotfire (etc.).
- Ability to manage multiple projects and conflicting priorities; flexibility when priorities change.
- Excellent written and verbal communication and strong organizational/documentation skills.

Work Location/Conditions:
- Remote work within the United States; not considering applicants residing/working in AK, AZ, HI, MI, or TN.
- Travel to Cambridge, MA corporate location several times per year and to other events as needed.
- Must have a suitable remote work setup (privacy, reliable internet, phone, and ability to participate in video conferences).