Senior Manager Statistical Programming

Vor Bio•Boston, MA

About The Position

The Senior Manager, Statistical Programming provides hands-on statistical programming leadership and support for assigned clinical studies, collaborating with Biostatistics, Clinical Data Management, Clinical Operations, Safety, and other study functions. The role leads the design, development, validation, and quality control of SAS programs used to access, transform, analyze, report, and submit clinical trial data. The Senior Manager serves as lead programmer for assigned studies, provides technical guidance to project teams, and ensures programming deliverables are accurate, consistent, and completed on time. The position supports clinical study programming from analysis planning and mock tables, figures, and listings (TFLs) through database locks, study reports, and regulatory submissions. It develops and validates SDTM and ADaM datasets and TFLs, maintains programming documentation and traceability, resolves complex programming and data issues, and contributes to programming standards and process improvement. The role also provides peer review and technical guidance to less experienced programmers. The position requires a master’s degree in a relevant discipline and at least seven years of statistical programming experience in a pharmaceutical, biotechnology, or CRO environment. The salary range is $190,000–$205,000 per year. Vor describes its benefits as including comprehensive health coverage, flexible paid time off, generous parental leave, a competitive 401(k), education assistance, wellness resources, and financial security resources.

Requirements

Master’s degree in Statistics, Mathematics, Computer Science, or a related discipline.
At least 7 years of statistical programming experience in a pharmaceutical, biotechnology, or CRO environment.
Strong hands-on SAS programming skills and experience with clinical trial reporting.
Strong knowledge of CDISC standards, including SDTM, ADaM, metadata, controlled terminology, data flow, and FDA electronic submission requirements.
Experience independently developing and validating analysis datasets, programming specifications, and TFLs.
Demonstrated experience serving as lead programmer for Phase 2 or Phase 3 clinical studies and independently managing study-level programming deliverables.
Good understanding of clinical development, medical data, and common safety and efficacy domains.
Strong analytical, problem-solving, debugging, and quality-control skills.
Ability to manage multiple study deliverables, adapt to changing priorities, and work effectively with cross-functional teams.
Strong written and verbal communication skills.

Nice To Haves

Experience in autoimmune disease, neurology, or rare-disease clinical development.
Working knowledge of R or other programming technologies.

Responsibilities

Serve as lead study programmer; support review of statistical analysis plans, development of mock TFLs, programming dry runs, and production of draft and final TFLs.
Develop, validate, and maintain SDTM and ADaM datasets, programming specifications, metadata, and supporting documentation.
Program and validate tables, figures, and listings for efficacy, safety, pharmacokinetic, pharmacodynamic, and clinical outcome assessments.
Design and develop SAS programs, macros, and reusable utilities using Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, and ODS.
Transform and integrate data from EDC, IRT, laboratory, eCOA, and other external sources.
Perform quality control reviews of SAS programs, datasets, specifications, logs, and outputs produced by other programmers.
Investigate and resolve complex data, derivation, programming, and reporting issues with limited supervision.
Support database locks, safety updates, clinical study reports, publications, and other study deliverables.
Support regulatory submissions by preparing and validating SDTM, ADaM, define.xml, SDRG, ADRG, annotated CRFs, and related submission components.
Review and resolve CDISC and submission validation findings.
Apply MedDRA, WHODrug, controlled terminology, and other applicable industry standards.
Maintain traceability from source data through SDTM, ADaM, and final statistical outputs.
Contribute to programming standards, templates, automation, and process improvement initiatives.
Provide technical guidance and peer review to less experienced programmers and contribute to their technical development as needed.