jazzhr
Senior Statistical Programmer
Rhythm Pharmaceuticals
Boston, USA
Full-time
Mid Level
Hybrid
USD 90000-135000 yearly
Discovered 1 weeks ago
Free
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- 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.
- 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; experience with R or other modern programming tools is a plus.
- Deep knowledge of CDISC standards, including SDTM, ADaM, define.xml, reviewer guides, and electronic submission requirements in eCTD format.
- Experience supporting study-level and integrated analyses, including ISS/ISE or other cross-study deliverables, with strong understanding of clinical trial reporting and regulatory submission processes.
- Able to work independently, manage priorities, collaborate cross-functionally, and deliver high-quality work in a fast-paced environment.
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