Hybrid Senior Statistical Programmer - Biotech Data Lead

Rhythm Pharmaceuticals Inc.; Boston (MA); Hybride; USD 90 000 - 135 000; Plein temps

Résumé du poste

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

This role provides hands-on statistical programming support across studies, regulatory submissions, and cross-functional development activities. You will deliver high-quality analysis datasets, tables, listings, and figures; contribute to submission deliverables; and collaborate with Biostatistics, Data Management, Clinical Development, Medical

Qualifications

• MS or equivalent degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related discipline; advanced degree preferred.
• 3+ 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; R or other tools a plus.
• Deep knowledge of CDISC standards (SDTM, ADaM, define.xml, reviewer guides) and eCTD submission requirements.
• Experience with study-level and integrated analyses, ISS/ISE or cross-study deliverables; strong regulatory submission understanding.

Responsabilités

• Lead or support programming activities for clinical studies, including development, validation, and QC of analysis datasets, tables, listings, and figures for reports and submissions.
• Serve as study lead programmer, partnering with Biostatistics, Data Management, Clinical Development, Medical Writing, Regulatory, and vendors to deliver high-quality results on time.
• Develop and maintain ADaM specs, TLF shells, documentation, reusable macros, and study-level programming standards.
• Contribute to protocols, SAPs, CRF design, edit checks, SDTM specs, and submission strategy for traceability and consistency.
• Support regulatory submission readiness, including prepare/review define.xml, reviewer guides, and submission-ready datasets.
• Identify risks, drive issue resolution, and propose process improvements for quality and efficiency; mentor junior programmers when applicable.

Description du poste

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

This role provides hands-on statistical programming support across studies, regulatory submissions, and cross-functional development activities. You will deliver high-quality analysis datasets, tables, listings, and figures; contribute to submission deliverables; and collaborate with Biostatistics, Data Management, Clinical Development, Medical