Director, Biostatistician

Join 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.

POSITION SUMMARY

The Director Biostatistician, will lead implementation of modern and innovative trial/experimental designs, statistical models, and analysis and data exploration methodologies at the study or project level, and you will be responsible for all statistical work, scientific and operational, in collaboration with the clinical trial teams and other quantitative partners in the Early Development – Advanced Quantitative Sciences team.

KEY RESPONSIBILITIES

• Provide strategic leadership as Vor’s global area expert in statistical, data science, programming, and data management.
• Provide biostatistical input in overall clinical development strategies, protocol design, statistical analysis plan (SAP), and regulatory interactions including briefing book, submissions, adequately address regulatory agencies’ requests and positions.
• Responsible for planning, monitoring, analyzing global clinical studies and coordinating the development and review of statistical aspects of regulatory submissions.
• Manage and oversee vendors as credible areas of experts from biostatistical, programming, and DM aspect, including CROs, IRT, eCOA, etc.
• Internally collaborate with cross-functional teams including global medical, clinical operations, regulatory, safety, etc. to ensure efficient and effective execution of global clinical trials.
• Oversee execution of global statistical analyses, including tables, listings and figures, preparation of the statistical methods and results of the overall summaries, clinical study reports, and statistical thinking in supporting the data interpretation, conclusion and decision making.
• Support medical team and external expert committee in programming specific global study related dataset to ensure efficient medical and safety data review and monitoring.
• Provide guidance and support to data collection and design and analysis for global studies from various data streams, including CRF designs, eCOA data collection, and other data platforms for collections.
• Effective management of blinded and unblinded IDMC related activities from strategies, charters, SAP, to generation of TLFs.
• Maintain up to date statistical methods, industry standards, regulatory requirements, and any other guidance or new development that will benefit RemeGen’s global clinical development programs.
• Preparation of related clinical studies for eCTD clinical modules, familiar with CDISC standards, review and prepare IWRS (interactive web-based randomization system) specs, ADaM Specs, review define document and reviewer guide.
• Support overall molecule development and commercialization strategies including publication strategies by providing statistical thinking, expertise on additional post hoc analysis and important inferences and interpretation of results.
  
  

REQUIREMENTS

POSITION SUMMARY

The Director Biostatistician, will lead implementation of modern and innovative trial/experimental designs, statistical models, and analysis and data exploration methodologies at the study or project level, and you will be responsible for all statistical work, scientific and operational, in collaboration with the clinical trial teams and other quantitative partners in the Early Development – Advanced Quantitative Sciences team.

KEY RESPONSIBILITIES

• Provide strategic leadership as Vor’s global area expert in statistical, data science, programming, and data management.
• Provide biostatistical input in overall clinical development strategies, protocol design, statistical analysis plan (SAP), and regulatory interactions including briefing book, submissions, adequately address regulatory agencies’ requests and positions.
• Responsible for planning, monitoring, analyzing global clinical studies and coordinating the development and review of statistical aspects of regulatory submissions.
• Manage and oversee vendors as credible areas of experts from biostatistical, programming, and DM aspect, including CROs, IRT, eCOA, etc.
• Internally collaborate with cross-functional teams including global medical, clinical operations, regulatory, safety, etc. to ensure efficient and effective execution of global clinical trials.
• Oversee execution of global statistical analyses, including tables, listings and figures, preparation of the statistical methods and results of the overall summaries, clinical study reports, and statistical thinking in supporting the data interpretation, conclusion and decision making.
• Support medical team and external expert committee in programming specific global study related dataset to ensure efficient medical and safety data review and monitoring.
• Provide guidance and support to data collection and design and analysis for global studies from various data streams, including CRF designs, eCOA data collection, and other data platforms for collections.
• Effective management of blinded and unblinded IDMC related activities from strategies, charters, SAP, to generation of TLFs.
• Maintain up to date statistical methods, industry standards, regulatory requirements, and any other guidance or new development that will benefit RemeGen’s global clinical development programs.
• Preparation of related clinical studies for eCTD clinical modules, familiar with CDISC standards, review and prepare IWRS (interactive web-based randomization system) specs, ADaM Specs, review define document and reviewer guide.
• Support overall molecule development and commercialization strategies including publication strategies by providing statistical thinking, expertise on additional post hoc analysis and important inferences and interpretation of results.
  
  

REQUIREMENTS

At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond.

As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Please visit our website at https://www.vorbio.com/ for more information.