Senior Manager, Statistical Programming - Autoimmune Trials

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

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