Job Requirements:
• Own development, finalization, and maintenance of SAPs for preclinical GLP studies, clinical pilots, and IND-enabling programs.
• Lead statistical design and justification of primary domain-specific endpoints (ΔMDH_BSS and ΔMDH_SSS) and supportive concordance analyses.
• Define and lock multivariate methods, including Mahalanobis Distance with shrinkage covariance, Spearman-based directional concordance, and sensitivity analyses.
• Prespecify and govern exploratory multivariate analyses (clustering, PCA, UMAP, OPLS) with strict non-inferential framing.
• Ensure FDA CBER–aligned language, table shells, figure shells, and interpretive boundaries across protocols, SAPs, and briefing documents.
• Partner closely with the CMO and Clinical Operations Lead on endpoint feasibility, analysis timing, and interim readouts.
• Serve as the statistical authority in interactions with regulators, DSMBs, IRBs, and external statistical reviewers.
• Oversee statistical QC, reproducibility, and audit readiness.
Required Qualifications:
• PhD or MS in Biostatistics, Statistics, or a closely related field.
• 8+ years of experience supporting early-phase clinical development in biotech or pharma.
• Direct authorship or ownership of SAPs included in IND submissions.
• Strong expertise in nonparametric methods, multivariate analysis, distance-based metrics, and small-N inference.
• Demonstrated ability to write in FDA statistical reviewer style.
• Comfort operating in exploratory settings with high scientific uncertainty.
Highly Desirable Experience:
• Experience with rare disease, ophthalmology, or inflammation-focused programs.
• Prior interaction with FDA statistical reviewers or advisory committees.
• Experience governing exploratory ML/AI-adjacent analyses in a regulatory context.
• Ability to translate complex statistical concepts to clinicians and executives.
