Teams at Precision For Medicine

Lead statistical strategy across clinical development: design consultation, protocol and SAP authorship/review, sample size and randomization oversight, review analyses and clinical study reports, support regulatory submissions and DMC reporting, serve as SME, mentor statisticians, and coordinate with sponsors and vendors for complex programs.

Lead statistical strategy and execution across clinical development, including study design consultation, sample size and SAP authoring/review, regulatory submission leadership, DMC reporting, mentoring statisticians, and partnering with sponsors and vendors on complex programs.

Manage clinical safety activities, including safety management plans, serious adverse event case processing, medical coding, expectedness assessments, narrative writing, regulatory reporting, quality control, safety database setup, reporting plans, training, and SOP development. Collaborate with sponsors, vendors, study teams, and site personnel while ensuring compliance with FDA, ICH, and global safety regulations.