Director, Biostatistics

Responsibilities

• Statistical Strategy & Clinical Trial Design
• Serve as the study and program-level statistical lead for one or more clinical programs, with end-to-end biostatistical ownership from study design through regulatory submission.
• Develop, author, and co-author statistical analysis plans (SAPs), sample size justifications, randomization strategies, and adaptive or novel trial design frameworks suited to rare disease and small-population contexts.
• Apply innovative statistical methodologies including Bayesian approaches, adaptive designs, andestimandframeworks per ICH E9(R1) to maximize information efficiency in limited-sample studies.
• Collaborate with Clinical Development, Translational Science, and Clinical Pharmacology to integrate quantitative evidence from early development into late-stage design decisions.
• Provide statistical input to clinical development plans, protocol design, go/no-go decision frameworks, and feasibility assessments.
• Regulatory Affairs & Submission Leadership
• Author and review statistical sections of regulatory documents including INDs, investigator brochures, briefing books, CSRs, and eCTD/CTD module submissions to FDA, EMA, and other health authorities.
• Represent Vor's Biostatistics function, asappropriate, in regulatory agency meetings (FDA Type A/B/C meetings; EMA scientific advice), preparing statistical positions and responding to agency questions.
• Ensure compliance with applicable ICH guidelines (e.g.,E6, E8, E9, E9(R1), E10, E17) and FDA/EMA statistical guidance documents throughout the clinical development lifecycle.
• Maintaincurrent knowledge of evolving regulatory expectations for rare disease programs, including implications of Orphan Drug and Breakthrough Therapy designations on study design and evidence standards.
• Data Analysis, Reporting & Integrity
• Oversee execution of all statistical analyses including interim analyses,primary/finalanalyses, safety reviews, and ad hoc requests, ensuring accuracy, reproducibility, and regulatory compliance.
• Lead generation and review of Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory packages, working closely with statistical programming.
• Review and approve CDISC-compliant SDTM andADaMdataset specifications, define.xml documents, and reviewer's guides for regulatory submissions.
• Oversee IDMC/DSMB activities including charter and SAP development, preparation of unblinded analyses, and coordination with independent statisticians.
• Ensure all statistical deliverables meet ICH E3 (CSR structure), CDISC, and applicable FDA/EMA technical standards.
• Cross-Functional Collaboration
• Partner with Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Safety, and Medical Writing to embed statistical rigor throughout the study lifecycle.
• Collaborate with Data Management on CRF design, data validation rules, database structures, andeCOA/ePRO platform specifications.
• Provide statistical input to publication strategies, scientific communications, and clinical evidence pla

Benefits

Additional Information

J oin Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide. When you join Vor, you're not just working on a medicine. You're part of a mission to redefine the future of autoimmune care. Why Work at Vor? Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with potential beyond one indication - a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren's syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies. Location: Boston, MA preferred The Director, Biostatistics serves as a senior individual contributor to statistical leadership at Vor Biosciences, providing strategic and operational oversight across multiple clinical programs. Reporting to the Head of Biometrics this individual will serve as Vor's global expert in biostatistical science, with accountability for all aspects of clinical trial design, statistical methodology, regulatory submission deliverables, and cross-functional scientific partnership. This is a hands-on, high-impact role in a lean, mission-driven biotech environment where the Director will function as a study and program statistical lead with both technical depth and enterprise-wide strategic influence.

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