Vor Bio
Director, Biostatistics
Boston, MA · Director
Sponsorship not specifiedDetected 9 days ago
PythonData AnalysisStatisticsLead GenerationSAPPharmacologyFDA RegulatorySASExperimental DesignLeadershipCommunicationCollaborationMentoringBiostatisticsRegulatory Affairs
About the role
- When you join Vor, you're not just working on a medicine.
- Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases.
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.
- 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.
- 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.
Requirements
- 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.
- Familiarity with CDISC standards (SDTM,ADaM), eCTD submission requirements, and reviewer's guide preparation.
- 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).
- Master's degree (MS/MA) in Biostatistics or Statistics with extensive industry experience may be considered.
- Education
- Required Experience
- Minimum 10 years of pharmaceutical/biotech industry experience in clinical biostatistics, with at least 5 yearsina senior or program-lead capacity.
- Demonstrated program-level statistical ownership from protocol design through regulatory submission (IND, NDA/BLA, or MAA).
- Demonstrated expertise applying the ICH E9(R1) Estimand Framework in clinical development programs, including estimand definition, intercurrent event strategies, alignment of study objectives, endpoints and analyses, development of sensitivity analyses, interpretation of treatment effects, and support of regulatory interactions and submissions. Experience with adaptive trial designs preferred.
- Prior experience at a clinical-stage biotech with responsibility for building or scaling a biometrics function.
Nice to have
- PhD in Biostatistics, Statistics, or a closely related quantitative discipline strongly preferred.
- Experience with adaptive trial designs preferred.
- Proficiencyin SAS (required)
- R strongly preferred
- Python or additional statistical languages a plus.
- Preferred Experience
Benefits
- 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.
- Partner with Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Safety, and Medical Writing to embed statistical rigor throughout the study lifecycle.
Company info
- Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond.
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