Hybrid Statistical Programming Manager

rhythmpharmaceuticals; Boston (MA); Hybrid; USD 110,000 - 165,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Rhythm Pharmaceuticals in Boston is seeking a Manager, Statistical Programming to join our Biostatistics and Statistical Programming team. This role provides hands-on programming support across clinical studies, regulatory submissions, and cross-functional development activities.

You will deliver high-quality analysis datasets, tables, listings, and figures; contribute to study-level deliverables; mentor programmers; and help shape standards.

Qualifications

• MS or equivalent in Statistics, Biostatistics, Mathematics, Computer Science, or related discipline; advanced degree preferred.
• 5+ years statistical programming experience in biotech, pharma, or CRO settings; vendor oversight experience preferred but not required.
• Strong hands-on SAS expertise and CDISC standards knowledge.

Responsibilities

• Lead or support statistical programming activities for assigned clinical studies, including development, validation, and quality control of analysis datasets, tables, listings, and figures for study reports, regulatory submissions, and internal decision-making.
• Serve as a study lead programmer or programming representative, partnering with Biostatistics, Data Management, Clinical Development, Medical Writing, Regulatory, and external vendors to deliver high-quality results on time.
• Develop, review, and maintain ADaM specifications, TLF shells, programming documentation, reusable macros, and study-level programming standards in alignment with company procedures and regulatory expectations.
• Provide input into protocols, statistical analysis plans, CRF design and annotation, edit checks, SDTM specifications, integrated data review, and submission strategy to ensure traceability, consistency, and efficient downstream analysis.
• Support regulatory submission readiness, including preparation and review of define.xml, reviewer guides, submission-ready datasets, and related documentation in compliance with CDISC and global regulatory requirements.
• Identify programming risks, drive issue resolution, and recommend process improvements that enhance quality, scalability, efficiency, and inspection readiness across studies and programs.
• Depending on level, mentor junior programmers, provide technical guidance, contribute to resource planning, oversee vendor deliverables, and help shape departmental standards, tools, and best practices.

Skills

SAS programming

SAS/STAT

SDTM/ADaM

Macro development

Regulatory submissions

R

Education

Master's degree in Statistics/Biostatistics/CS

Tools

SAS

R

Job description

Rhythm Pharmaceuticals in Boston is seeking a Manager, Statistical Programming to join our Biostatistics and Statistical Programming team. This role provides hands-on programming support across clinical studies, regulatory submissions, and cross-functional development activities.

You will deliver high-quality analysis datasets, tables, listings, and figures; contribute to study-level deliverables; mentor programmers; and help shape standards.