Own the development, finalization, and lifecycle management of Statistical Analysis Plans (SAPs) for preclinical GLP studies, early clinical programs, and IND-enabling trials.
Lead statistical design and justification of domain-specific primary endpoints and supportive concordance analyses.
Define, lock, and govern multivariate statistical methodologies, including distance-based metrics and sensitivity analyses.
Prespecify exploratory multivariate analyses with clearly defined non-inferential boundaries.
Ensure FDA CBER-aligned statistical language, table shells, figure shells, and interpretation standards across protocols, SAPs, and regulatory documents.
Collaborate closely with clinical leadership on endpoint feasibility, analysis timing, interim readouts, and interpretation strategy.
Act as the primary statistical authority in engagements with regulatory agencies, DSMBs, IRBs, and external reviewers.
Oversee statistical quality control, reproducibility, audit readiness, and documentation compliance.
