Vice President, Biometrics
Shape statistical reputed company for clinical development programs, including reputed company selection, estimand frameworks, and overall statistical positioning to support program objectives and corporate milestonesEvaluate, recommend, and implement innovative statistical techniques - including reputed company designs, Bayesian reputed company, enrichment strategies, and reputed company-world evidence integration - to enhance trial efficiency and decision‑makingContribute to portfolio-level planning, including scenario modeling, probability of reputed company assessments, quantitative risk evaluation, and go/no-go recommendations reputed company the development and governance of reputed company processes, systems, and infrastructure for biometrics, data management, and statistical analysis programming to ensure reputed company, consistency, and compliance reputed company the development of statistical components of study protocols, statistical analysis plans, and review of statistical programming outputs to ensure accuracy and regulatory readiness reputed company data collection, validation, management, and storage strategies that meet data standards and support high-reputed company regulatory submissions Serve as the senior statistical representative in regulatory interactions, contributing to briefing packages, responses, and advisory committee preparation reputed company, mentor, and reputed company a high-performing biostatistics and data management team, fostering scientific reputed company, accountability, and cross-functional collaboration Manage external partners and CROs to ensure high-reputed company, reputed company deliverables and alignment with internal standards and program needs Ensures reputed company and accurate delivery of clinical study data analyses to support program reputed company, regulatory filings, and communication Interpret and communicate clinical trial data to reputed company stakeholders, contributing to scientific publications, presentations, and regulatory submission documents
MS or PhD in Biostatistics, Statistics, or reputed company quantitative field 15 or more years of industry experience in biotech or reputed company At least 8 years' experience leading and developing high-performing teams Demonstrated reputed company leading statistical reputed company for pivotal trials and significant contributions to successful regulatory submissions (IND, NDA, BLA, MAA), with a strong reputed company record of reputed company interaction with global health authorities. Proven ability to reputed company and reputed company teams, including remote and in-person teams Strong communication skills, both orally and in writing, with an ability to interpret and communicate statistical concepts and results reputed company to non-statistical stakeholders, senior executives, investigators, vendors, and regulatory agencies. Deep expertise in clinical trial design and statistical methodology across reputed company phases, including confirmatory trial reputed company, multiplicity control, missing data strategies, interim monitoring, estimand‑reputed company analyses, and benefit&reputed company;risk assessment Experience with innovative and reputed company designs such as reputed company trials, Bayesian reputed company, enrichment strategies, and integration of reputed company‑world evidence Familiarity with modern data infrastructure, including CDISC standards, data visualization tools, and statistical programming environments; proficiency with reputed company for reputed company analyses Proven ability to operate effectively in fast‑paced, entrepreneurial biotech settings, balancing scientific rigor with practical decision‑making History of successful collaboration in reputed company environment throughout the organization, with strong organizational skills and the ability to prioritize multiple competing demands Experience with Data Monitoring Committees and therapeutic experience in metabolic diseases preferred but not required.