Location: Boston, MA preferred

The Associate Director, Clinical Data Management (CDM) is an individual contributor and leadership role within Vor's Biometrics organization, responsible for strategic oversight and operational delivery of all clinical data management activities across Vor's clinical portfolio. This individual will serve as one of Vor's internal CDM experts leading study and program-level data governance, owning EDC architecture and data standards, managing CRO and vendor partnerships, and ensuring continuous regulatory inspection readiness. 

This role will be accountable for department-level strategy, SOP ownership, regulatory inspection representation as a named CDM subject matter expert, and cross-regional data integration from multi-national studies. The Associate Director serves as a senior escalation point and represents the CDM function at program governance forums and regulatory interactions. 

Key Responsibilities 

1. CDM Strategy & Portfolio Oversight 

• Contribute to the strategic and operational leadership for multiple CDM activities across Vor's clinical portfolio, from protocol synopsis through database lock, archiving, and regulatory submission. 

• Serve as the CDM functional lead on program teams, contributing to clinical development plans, protocol design, and study feasibility assessments from a data quality and operability perspective. 

• Define and communicate CDM strategy, standards, and milestone timelines at the study and program level; identify risks early and communicate mitigation plans to senior leadership. 

• Partner with Biostatistics and Statistical Programming to ensure seamless data flow from EDC through SDTM/ADaM datasets and downstream regulatory analyses. 

2. EDC Platform Ownership & Data Standards — Medidata Rave 

• Serve as Vor's primary subject matter expert (SME) and platform owner for Medidata Rave EDC, governing the full ecosystem: study build, library management, edit check strategy, change control, and system validation. 

• Lead development and governance of Vor's CDASH-aligned CRF standards library within Medidata Rave — ensuring consistency, reusability, version control, and regulatory/submission alignment across all programs. 

• Oversee CRF design, database build specifications, UAT strategy, and production release quality control across all active studies. 

• Ensure EDC configurations comply with CDISC CDASH/SDTM standards, facilitating optimal downstream dataset programming for regulatory submissions. 

• Evaluate and implement emerging Medidata capabilities (e.g., eConsent, eCOA integrations, Medidata AI data monitoring) to advance quality and operational efficiency. 

• Maintain governance of edit check specifications, data review guidelines, and coding conventions (MedDRA, WHODrug) across all Vor studies. 

3. Cross-Regional Data Integration & Bridging Studies 

• Lead the CDM strategy for multi-regional clinical trials, including studies with non-US-originated or non-US-concurrent data (e.g., bridging studies, ICH E17-compliant global programs). 

• Oversee data transfer, reconciliation, and harmonization from non-US regional CROs and data platforms, ensuring data integrity when integrating datasets from non-US investigational sites or partners into global submissions. 

• Partner with Regulatory Affairs and Biostatistics to define data requirements for integrated global analyses and data pooling strategies (per ICH E17) for FDA and EMA submissions. 

• Ensure regional data collection practices — including eCRF language localization, coding dictionary alignment, and site training materials — satisfy both local regulatory requirements and Vor global data standards. 

• Manage data transfer specifications and reconciliation protocols for all third-party data streams: central labs, IRT, safety databases, eCOA, and regional CRO-generated datasets. 

4. Regulatory Inspection Readiness & Direct Inspection Representation 

• Ensure Vor's CDM documentation, TMF data management sections, and EDC audit trails are maintained in a state of continuous inspection readiness throughout the study lifecycle. 

• Serve as the CDM subject matter expert and primary spokesperson in regulatory inspections (FDA, EMA, competent authority), audits, and quality reviews — directly answering inspector and auditor questions on data management practices, EDC systems, data integrity, and audit trail review. 

• Prepare CDM inspection packages including data management plans, system validation documentation, audit trail narratives, and data quality metrics for regulatory review. 

• 5. CRO & Vendor Management 

• Serve as Vor's senior CDM oversight lead for external CRO DM partners — including contract scope definition, performance governance, issue escalation authority, and quality review. 

• Establish and enforce CDM expectations, SOW deliverables, and quality metrics for all external vendors: CROs, EDC service providers, central labs, IRT vendors, and eCOA/ePRO platforms. 

• Review and approve all key DM vendor deliverables: data management plans, CRF completion guidelines, edit check specifications, data transfer agreements, and database lock packages. 

• Lead vendor qualification activities and contribute to CRO selection processes as a CDM technical evaluator. 

6. Quality, Compliance & SOP Governance 

• Develop, maintain, and continuously improve Vor's CDM SOPs, work instructions, templates, and data management plans in alignment with ICH E6(R3), FDA 21 CFR Part 11, EU Annex 11, GCDMP, and CDISC standards. 

• Ensure compliance with electronic records and electronic signatures regulations across all EDC systems and data management platforms. 

• Track and report data quality metrics, query resolution rates, cleaning milestones, and database lock timelines to program teams and leadership. 

7. Cross-Functional Collaboration 

• Collaborate closely with Biostatistics, Statistical Programming, Clinical Operations, Regulatory Affairs, Medical Writing, and Safety to ensure CDM activities support all downstream deliverables. 

• Partner with Clinical Operations on site training, data entry guidance, and site data quality monitoring. 

• Provide CDM input into clinical study reports, regulatory briefing documents, and submission-ready data packages. 

• Represent CDM on study teams, program governance boards, and senior leadership forums. 

8. Leadership & Talent Development 

• Provide mentorship, technical guidance, and professional development support to Sr. Data Managers and Data Managers within the CDM team. 

• Contribute to workforce planning and hiring, helping define and scale CDM capabilities as Vor's pipeline grows. 

• Foster a high-performance, quality-first team culture aligned with Vor's clinical mission. 

Qualifications 

Education 

• Bachelor's degree in Life Sciences, Health Informatics, Computer Science, or related field required. 

• Advanced degree (Master's or equivalent) preferred. 

• CCDM (Certified Clinical Data Manager) certification is a plus. 

Required Experience 

• Minimum 10 years of clinical data management experience in pharmaceutical, biotech, or CRO settings, with at least 3 years in a senior lead or management role. 

• Expert-level proficiency with Medidata Rave EDC — including study build, CRF design, edit check authoring, library management, UAT oversight, and production release governance. 

• Demonstrated prior experience as the named CDM representative in FDA or EMA regulatory inspections — directly answering inspector questions on data management practices, audit trails, and data integrity. 

• Hands-on experience with multi-regional clinical data management including integration of data from China-based or other non-US studies, data transfer reconciliation, and bridging study data strategies. 

• Deep knowledge of CDISC standards (CDASH, SDTM), ICH guidelines (E6, E8, E9, E17), FDA 21 CFR Part 11, EU Annex 11, and GCDMP. 

• Proven CRO and vendor oversight experience across full study lifecycles from startup through database lock and archiving. 

• Proficiency with coding dictionaries (MedDRA, WHODrug) and data review/cleaning methodologies. 

Preferred Experience 

• Background in autoimmune disease and/or rare disease is a plus.  

• Prior experience with front-line communications during regulatory inspections.  

• Prior experience building or scaling a CDM function in a lean, clinical-stage biotech environment. 

• Familiarity with eSource, decentralized trial (DCT) components, and real-time data monitoring technologies. 

• Experience with Medidata Rave Architect and/or Rave EDC Modules (eConsent, eCOA, Medidata AI). 

• Working knowledge of R/R Shiny/Posit Connect or other similar tools for data quality review, reconciliation, and dashboards is a plus.  

Skills & Competencies 

• Demonstrated ability to communicate complex data management concepts clearly and concisely — both in polished written deliverables and confident oral presentations — to diverse audiences including clinical teams, regulatory inspectors, senior leadership, and external partners. 

• Strategic thinking with the ability to anticipate downstream data quality and submission risks and take proactive, documented action. 

• Exceptional attention to detail combined with ability to manage multiple concurrent programs under tight timelines. 

• Ability to lead and influence cross-functionally without requiring direct authority over all stakeholders. 

• Comfort operating hands-on in a lean, fast-paced clinical-stage biotech alongside strategic departmental oversight. 

• Strong vendor management and project delivery track record for high-quality data packages on time. 

• Collaborative, patient-centered mindset aligned with Vor's mission. 

The salary range for the Associate Director, Clinical Data Management is expected to be between $185,000 and $210,000 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.

Location: Boston, MA preferred

The Senior Data Manager is responsible for all data management activities from study start-up through database lock and archiving and independently supporting the needs of the clinical study and programs of studies.  The Senior Data Manager will ensure completeness, accuracy and consistency and meet the standards of quality analysis and reporting to regulatory bodies.  In addition, the Senior Data Manager has an active role in continuous improvement and acts as a leader in the department as demonstrated by successful mentoring and consistent study delivery over time. 
 
Responsibilities: 
 

• Serves as data lead for one or more clinical trials, assuming responsibility for all data management activities, including access levels and permissions. 

• Proactively drive quality and efficiency to meet timelines and milestones for data management in close collaboration with cross functional study team(s) 

• Conduct oversight of data management activities internally and performed by the CROs and other 3rd party vendors (IRT, Safety, Lab, etc.) to meet Vor obligations and business objectives throughout study (ies) life cycle i.e. from protocol synopsis through database release and submission. 

• Serve as a first point of contact for DM partners to ensure established milestones and deliverables are met with the highest degree of quality 

• Ensure the internal and external partners align and conform to data management expectations for the assigned compound and/or indication. 

• Review and provide input for all DM documentation - CRF design and completion Guidelines, Data Management Plan, Data Transfer Specifications, etc. 

• Oversee edit check specifications to support data collection and analysis required per protocol. 

• Ensure the clinical database adheres to Clinical Data Acquisition Standards Harmonization guidelines allowing for optimal SDTM dataset programming. Suggest design for standard and non-standard data collection, identify any gaps in data collection, and challenge collection of unnecessary data. 

• Participate in the creation of the clinical development plan, describing the clinical development strategy and possible innovative trial designs.  

• Set quality expectations and timelines for data management deliverables and regularly follow up on data management milestones.  Ensure inspection readiness at all times. 

• Set expectations and communicate and a transparent, clear way and motive team members to work towards achieving the clinical goals. 

•  Follow department and company standard operating procedures (SOPs), forms, templates and policies. Provide feedback and update these guidelines as needed. 

•  Develop, review, and maintain all study Data Management documentation. 

• Take responsibility for and guide effective quality control (QC) review and user acceptance testing (UAT) of the clinical database prior to its release into production, including oversight of staff performing these tasks. 

•  Ensure data are properly reviewed in accordance with the Data Management Plan (DMP) and guidelines and that cleaning is effective and timely. 

• Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager. 

•  Provide input into improving the efficiency of data management tasks. 

•  Lead and participate in intradepartmental or interdepartmental process and quality improvement initiatives. 
   
   

Requirements 
 
 

•  Bachelor's Degree in computer sciences, health-related sciences, or relevant field and 7+ years of Data Management experience.  

• Proven hands-on, direct, individual contributor experience with all data management tasks as well as DM vendor oversight to meet aggressive timelines of high-quality data deliverables. 

• Extensive hands-on experience with clinical data management practices within industry sponsored clinical trials. 

• In depth knowledge of industry leading eCRF tools and well versed in industry trends and emerging technologies supporting data collection.  

• Proficient experience using commercial clinical data management systems and/or EDC products e.g. Medidata Rave. Must have Medidata RAVE experience.  

• Strong project management; exhibits expertise in metrics analysis and reporting methodologies. 

• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, related regulatory requirements. 

• Contribute to the growth and development of the DM team. 

• Excellent verbal and written communication skills. 

•  Professional attitude and strong interpersonal skills. 

•  Ability to work well with a multi-disciplinary team of professionals. 

•  Flexible attitude with respect to work assignments and new learning. 

•  Ability to prioritize workload. 

•  Superior attention to detail. 

•  Understanding of clinical research and the relationship of Data Management in the clinical study process. 

•  Strong technical aptitude and ability to adapt to multiple data management platforms. 

•  Strong knowledge of electronic data capture (EDC) clinical data management systems. 

• Strong computer skills (Microsoft Office Suite, Medidata Rave) and ability to understand and adapt to various information technology (IT) systems. 
   

Preferred Requirement(s): 

• Working knowledge of R/R Shiny/Posit Connect or other similar tools for data quality review, reconciliation, and dashboards is a plus.  

The salary range for the Senior Data Manager is expected to be between $170,000 and $190,000 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.

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. 

Key Responsibilities 

1. 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.

1. 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. 

1. 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.

1. 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 planning in partnership with Medical Affairs.

1. Vendor & CRO Oversight

• Serve as Vor's statistical representative in the selection, qualification, and oversight of CROs, statistical programming vendors, IRT providers, andeCOAplatforms. 
• 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.

1. 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.

1. 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 yearsina senior or program-lead capacity. 
• Demonstratedprogram-level statistical ownership from protocol design through regulatory submission (IND, NDA/BLA, or MAA). 
• Hands-on experience with adaptive designs, Bayesian methods, or novelestimandframeworks (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.
• Proficiencyin 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. 

Preferred Experience 

* 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).

Skills & Competencies 

• Demonstratedability 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 complexmethodologyinto clear language for non-statistical audiences. 
• Strong leadership and cross-functional influence without requiring direct line authority over all stakeholders.
• Comfortoperatingin a lean, fast-paced biotech with hands-on execution alongside strategic thinking. 
• Ability to build statistical processes, standards, and infrastructure from theground 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.

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.