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Rhythm Pharmaceuticals

Commercializes MC4R-targeted therapies for rare obesity

Senior Statistical Programmer

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeBoston, MA, USA

About the Job

Requirements

  • A Master of Science or equivalent degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related discipline is required.
  • At least 3 years of relevant statistical programming experience in biotech, pharma, or CRO settings is required.
  • Strong hands-on expertise in SAS programming, including Base SAS, SAS/STAT, SAS/GRAPH, SAS/SQL, SAS/ODS, and macro development is required.
  • Deep knowledge of CDISC standards, including SDTM, ADaM, define.xml, reviewer guides, and electronic submission requirements in eCTD format is required.
  • Experience supporting study-level and integrated analyses, including ISS/ISE or other cross-study deliverables, and a strong understanding of clinical trial reporting and regulatory submission processes are required.
  • The candidate must be able to work independently, manage priorities, collaborate cross-functionally, and deliver high-quality work in a fast-paced environment.
  • Candidates must be willing and able to work in the Boston office in coordination with their department and business needs.

Responsibilities

  • Lead or support statistical programming activities for assigned clinical studies, including developing, validating, and quality-controlling 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 by preparing and reviewing 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 to enhance quality, scalability, efficiency, and inspection readiness across studies and programs.

Desired Qualifications

  • An advanced degree is preferred.
  • Vendor oversight experience is preferred but not required.
  • Experience with R or other modern programming tools is a plus.
  • For manager-level candidates, experience mentoring programmers, overseeing external vendors, and contributing to resource planning or process improvement is a plus.

About the Company

Rhythm Pharmaceuticals

Commercializes MC4R-targeted therapies for rare obesity

Rhythm Pharmaceuticals focuses on developing therapies for rare neuroendocrine genetic obesity disorders, led by IMCIVREE (setmelanotide). IMCIVREE is an MC4R agonist that restores signaling in the MC4R pathway to curb hunger and regulate energy use; it is FDA, EC, and MHRA approved for Bardet-Biedl syndrome and certain POMC/PCSK1/LEPR deficiencies in patients aged 2 and older, with revenue from global sales. The company differentiates itself by pursuing precision medicine for MC4R pathway diseases and advancing additional MC4R programs like bivamelagon and RM-718. Rhythm’s goal is to broaden access to MC4R-targeted therapies for rare patient populations and grow its pipeline toward sustainable commercialization.

Company size
501-1,000
Company stage
IPO
Headquarters
Boston, MA
Founded
2008

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