Senior Manager Statistical Programming

Vor Bio • Boston, MA

23h • $190,000 - $205,000

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 is responsible for designing, developing, validating, and quality-controlling SAS programs used to access, transform, analyze, report, and submit clinical trial data.

As lead programmer for assigned studies, the Senior Manager provides technical guidance to project teams and ensures programming deliverables are accurate, consistent, and completed within established timelines. The position supports study programming from analysis-plan review and mock table, figure, and listing development through database locks, clinical study reports, and regulatory submissions. It also contributes to programming standards, automation, process improvement, and the technical development of less experienced programmers.

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, with the ability to independently manage 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 and 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 efficient SAS programs, macros, and reusable utilities using Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, and ODS.
• Transform and integrate data from EDC systems, IRT systems, laboratories, eCOA platforms, 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 clear 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.

Benefits

• Comprehensive health coverage.
• Flexible paid time off.
• Generous parental leave.
• Competitive 401(k).
• Education assistance.
• Wellness resources.
• Financial security resources. The posting does not specify the details of these resources.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior