Director, Biostatistics

Vor Bio•Boston, MA

11d•$230,000 - $250,000•Hybrid

About The Position

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.

Requirements

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.
Minimum 10 years of pharmaceutical/biotech industry experience in clinical biostatistics, with at least 5 years in a senior or program-lead capacity.
Demonstrated program-level statistical ownership from protocol design through regulatory submission (IND, NDA/BLA, or MAA).
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.
Proficiency in SAS (required); R strongly preferred; Python or additional statistical languages a plus.
Familiarity with CDISC standards (SDTM, ADaM), eCTD submission requirements, and reviewer's guide preparation.
Prior experience at a clinical-stage biotech with responsibility for building or scaling a biometrics function.
Experience in rare disease or immunology drug development.
Experience with small-sample trial design methodologies (e.g., single-arm studies, external control arms, historical data integration).
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.
Ability to build statistical processes, standards, and infrastructure from the ground up.
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.

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.
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.
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.
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.
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.
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.
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.