Principal Statistical Programmer

The Principal Statistical Programmer will lead and coordinate all statistical programming activities for cardiac safety trials, developing, testing, and maintaining SAS code to generate CDISC-compliant datasets (SDTM, ADaM). Responsibilities include producing and maintaining submission-ready datasets and electronic submission packages in accordance with FDA guidelines, creating and implementing data standards and macros, and researching new programming techniques. The role involves generating and interpreting compliance checks on CDISC-formatted datasets and supporting statistical analyses and regulatory requirements through client-facing discussions. Additionally, the Principal Statistical Programmer will manage direct reports, conduct onboarding and training, mentor junior staff, and lead team strategy meetings. They will also identify and implement process improvements, develop and maintain SOPs, SWIs, templates, and playbooks, and drive initiatives for future analyses, data quality, and standardization. Collaboration with cross-functional teams, management of client commitments, maintenance of deliverable statuses, and provision of consultation during sponsor and regulatory teleconferences are also key duties.