Hybrid Statistical Programmer — Biotech Data & Submissions Lead

Rhythm Pharmaceuticals Inc.

Boston (MA)

Hybrid

USD 110,000 - 165,000

Full time

14 days+

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Job summary

Rhythm Pharmaceuticals Inc. in Boston, MA seeks a Statistical Programmer to join our Biostatistics and Statistical Programming team.

The role provides hands-on programming across studies, regulatory submissions, and cross-functional development, delivering high-quality analysis datasets, tables, listings, and figures. Ideal candidates have 3–5 years in biotech/pharma statistical programming, strong SAS experience (Base SAS, SAS/STAT, SAS/GRAPH, SAS/SQL), and familiarity with CDISC standards

Qualifications

MS or equivalent degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related discipline; advanced degree preferred.
3-5 years relevant statistical programming experience in biotech, pharma, or CRO settings; vendor oversight experience preferred but not required.
Strong hands-on expertise in SAS programming, including Base SAS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ODS, and macro development; experience with R or other modern programming tools is a plus.

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 closely 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.