Senior Manager Statistical Programming

vorbiopharma; Boston (MA); On-site; USD 140,000 - 195,000; Full time

Job summary

Vor is seeking a Senior Manager of Statistical Programming to provide hands-on leadership for assigned clinical studies. You will design, validate, and QC SAS programs to access and report trial data, leading a team of programmers and ensuring timely, accurate outputs for regulatory submissions.

You will develop SDTM/ADaM datasets, definitions, and TFLs while transforming data from multiple systems. Strong communication and cross-functional collaboration are essential to drive study success in a

Qualifications

• Master's degree in Statistics, Mathematics, Computer Science, or related.
• 7+ years of statistical programming in pharmaceutical/biotech/CRO environments.
• Strong SAS programming and clinical trial reporting experience.
• Proficient in CDISC SDTM/ADaM, metadata, controlled terminology, and FDA submissions.
• Experience as a lead programmer for Phase 2 or 3 studies; capable of managing study deliverables.
• Solid understanding of clinical development, safety and efficacy domains.
• Excellent analytical, problem-solving, and communication skills.
• Experience in autoimmune disease, neurology, or rare diseases is preferred.
• R programming knowledge desirable.

Responsibilities

• Lead study programmer and review SAPs, mock TFLs, and SDTS outputs.
• Develop and validate SDTM/ADaM datasets, specifications, and metadata.
• Program and validate tables, figures, listings for efficacy, safety, and PK/PD data.
• Design and optimize SAS programs, macros, and reusable utilities.
• Transform data from EDC/IRT/lab/eCOA sources and integrate them.
• Conduct QC of SAS programs, datasets, logs, and outputs.
• Support regulatory submissions with define.xml, SDRG/ADRG and related components.
• Mentor and provide technical guidance to junior programmers.

Skills

SAS programming

CDISC standards

Lead programmer

Clinical trial reporting

Data management

Regulatory submissions

Cross-functional collaboration

Communication skills

Education

Master's degree in Statistics/Mathematics/CS

Tools

Base SAS

SAS Macro

SAS/STAT

SAS/GRAPH

ODS

R

Job description

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.

Senior Manager, Statistical Programming

Position Summary

The Senior Manager, Statistical Programming will provide hands‑on statistical programming leadership and support for assigned clinical studies and collaborate with Biostatistics, Clinical Data Management, Clinical Operations, Safety, and other study functions. This role is responsible for the design, development, validation, and quality control of SAS programs used to access, transform, analyze, report, and submit clinical trial data. The Senior Manager will serve as lead programmer for assigned studies, provide technical guidance to project teams, and ensure that programming deliverables are accurate, consistent, and completed within established timelines.

Essential Duties and 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 support 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 through preparation and validation of 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.

Knowledge and Skill Requirements

• Master's degree in Statistics, Mathematics, Computer Science, or a related discipline.
• Minimum of 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 a 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.
• Experience in autoimmune disease, neurology, or rare‑disease clinical development is preferred.
• Working knowledge of R or other programming technologies is desirable.

The salary range for this Senior Manager Statistical Programming position is expected to be betwee