Director, Biostatistics

Key Responsibilities

• 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, and estimand frameworks 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, as appropriate, 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.
• Maintain current 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/final analyses, 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 and ADaM dataset 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, and eCOA/ePRO platform specifications.
• Provide statistical input to publication strategies, scientific communications, and clinical evidence planning in partnership with Medical Affairs.

Vendor & CRO Oversight

• Serve as Vor's statistical representative in the selection, qualification, and oversight of CROs, statistical programming vendors, IRT providers, and eCOA platforms.
• Review and approve vendor-generated statistical deliverables for scientific quality, compliance, and timeliness; escalate and resolve issues proactively to protect program timelines and data integrity.

Standards, Infrastructure & Innovation

• Contribute to the development and maintenance of Vor's internal biostatistical standards, SOPs, templates (SAP, DMC charter, analysis specifications), and best practices.
• Champion adoption of modern statistical methods including Bayesian analysis, real-world data integration, model-based drug development, and simulation-based sample size approaches.
• Stay current with regulatory guidance, methodological advances, and industry benchmarks to continuously elevate Vor's statistical capabilities.

Leadership & Talent Development

• Provide mentorship and technical guidance to junior biostatisticians and cross-functional data scientists within the Biometrics organization.
• Contribute to workforce planning including defining resourcing needs and supporting recruitment and development of talent as Vor's pipeline expands.
• Foster a culture of scientific rigor, continuous learning, and collaborative excellence.

Qualifications

• Education: PhD in Biostatistics, Statistics, or a closely related quantitative discipline strongly preferred. Master's degree (MS/MA) in Biostatistics or Statistics with extensive industry experience may be considered.
• Required Experience: Minimum 10 years of pharmaceutical/biotech industry experience in clinical biostatistics, with at least 5 years in a senior or program-lead capacity. Hands-on experience with adaptive designs, Bayesian methods, or novel estimand frameworks (ICH E9(R1)). Track record of direct FDA and/or EMA interaction, including preparation and response to agency queries. Experience managing CRO statistical and programming relationships and vendor deliverable quality.
• Skills & Competencies: Demonstrated ability to communicate complex statistical concepts clearly and concisely to diverse audiences — including clinical, regulatory, and executive stakeholders — through both compelling written deliverables and confident oral presentations. Exceptional statistical reasoning with ability to translate complex methodology into clear language for non-statistical audiences. Strong leadership and cross-functional influence without requiring direct line authority over all stakeholders. Comfort operating in a lean, fast-paced biotech with hands-on execution alongside strategic thinking. Excellent written and oral communication; effective across regulatory, executive, and scientific forums. Strong project management skills; able to manage multiple programs simultaneously under tight timelines. Collaborative, patient-centered mindset aligned with Vor's mission in hematologic disease.

Pay

The salary range for the Director, Biostatistics is expected to be between $230,000 and $250,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.