Director, Biostatistics

Responsibilities

• Serve as the study and program-level statistical lead for clinical programs from design through regulatory submission
• Develop and author statistical analysis plans (SAPs), sample size justifications, and randomization strategies
• Apply innovative methodologies including Bayesian approaches and adaptive designs
• Author and review statistical sections of regulatory documents (INDs, CSRs, eCTD/CTD modules)
• Represent the Biostatistics function in regulatory agency meetings with the FDA and EMA
• Oversee execution of all statistical analyses, interim analyses, and safety reviews
• Review and approve CDISC-compliant SDTM and ADaM dataset specifications
• Oversee IDMC/DSMB activities and coordination with independent statisticians
• Manage CRO and vendor relationships, ensuring quality and timeliness of deliverables
• Provide mentorship and technical guidance to junior biostatisticians

Requirements

• PhD in Biostatistics, Statistics, or a related quantitative discipline (Master's with extensive experience considered)
• Minimum 10 years of pharmaceutical/biotech industry experience in clinical biostatistics
• At least 5 years in a senior or program-lead capacity
• Demonstrated program-level ownership from protocol design through regulatory submission (IND, NDA/BLA, or MAA)
• Hands-on experience with adaptive designs, Bayesian methods, or ICH E9(R1) estimand frameworks
• Track record of direct FDA and/or EMA interaction
• Proficiency in SAS (required); R strongly preferred
• Familiarity with CDISC standards (SDTM, ADaM) and eCTD submission requirements

Preferred Qualifications

• Experience in rare disease or immunology drug development
• Experience with small-sample trial design (single-arm studies, external control arms)
• Prior experience at a clinical-stage biotech scaling a biometrics function

About the Company

Vor Bio is a mission-driven biotech company focused on tackling autoimmune disease at its root. By advancing telitacicept, a dual BAFF/APRIL inhibitor, Vor aims to redefine the future of autoimmune care and change the course of disease for patients worldwide.