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Salary: USD 190,000 - 205,000 / annual
Vor Bio is seeking a Senior Manager of Statistical Programming to lead clinical trial data programming efforts for telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor in development for autoimmune diseases including myasthenia gravis, lupus, IgA nephropathy, and Sjögren's syndrome.
In this role, you will serve as the lead programmer for assigned clinical studies, providing hands-on statistical programming leadership and technical guidance to project teams. You will be responsible for the design, development, validation, and quality control of SAS programs used to access, transform, analyze, report, and submit clinical trial data.
Key responsibilities include:
- Serving as lead study programmer and supporting review of statistical analysis plans, development of mock TFLs (tables, figures, listings), programming dry runs, and production of draft and final TFLs
- Developing, validating, and maintaining SDTM and ADaM datasets, programming specifications, metadata, and support documentation
- Programming and validating tables, figures, and listings for efficacy, safety, pharmacokinetic, pharmacodynamic, and clinical outcome assessments
- Designing and developing efficient SAS programs, macros, and reusable utilities using Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, and ODS
- Transforming and integrating data from EDC systems, IRT systems, laboratories, eCOA platforms, and other external sources
- Performing quality control reviews of SAS programs, datasets, specifications, logs, and outputs produced by other programmers
- Investigating and resolving complex data, derivation, programming, and reporting issues with limited supervision
- Supporting database locks, safety updates, clinical study reports, publications, and other study deliverables
- Supporting regulatory submissions through preparation and validation of SDTM, ADaM, define.xml, SDRG, ADRG, annotated CRFs, and related submission components
- Reviewing and resolving CDISC and submission validation findings
- Managing multiple study deliverables, adapting to changing priorities, and working effectively with cross-functional teams including Biostatistics, Clinical Data Management, Clinical Operations, and Safety
You will ensure that programming deliverables are accurate, consistent, and completed within established timelines.
Requirements:
- Bachelor's degree in a scientific or quantitative discipline (e.g., statistics, mathematics, computer science, life sciences, or related field)
- Minimum 7 years of statistical programming experience in clinical trials or pharmaceutical research
- Advanced proficiency in SAS (Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, ODS)
- Strong knowledge of CDISC standards (SDTM, ADaM, define.xml)
- Experience with clinical trial data management and regulatory submission processes
- Proficiency with EDC systems and data integration from multiple sources
- Excellent problem-solving and analytical skills
- Ability to manage multiple study deliverables, adapt to changing priorities, and work effectively with cross-functional teams
- Strong written and verbal communication skills
- Experience in autoimmune disease, neurology, or rare-disease clinical development is preferred
- Working knowledge of R or other programming technologies is desirable
