Position located in Boston, MA

Responsibilities of the Principal Statistical Programmer:

• Manage and collaborate with external vendors and CROs to ensure high-quality deliverables.
• Serve as the lead statistical programmer on clinical studies, overseeing programming activities both internally and externally.
• Develop, validate, and maintain SAS programs for data manipulation, analysis, and reporting.
• Create and validate CDISC-compliant datasets and define.xml files for regulatory submissions.
• Generate and/or validate tables, listings, and figures (TLFs) for clinical study reports (CSRs) and publications.
• Collaborate closely with biostatistics, data management, clinical, and safety teams to ensure data quality and integrity.
• Provide programming support for regulatory interactions and submissions.
• Contribute to the development and implementation of standardized programming processes, macros, and automation tools to enhance efficiency.
• Ensure compliance with Good Programming Practices (GPP), ICH guidelines, and company SOPs.

Requirements of the Principal Statistical Programmer:

• MS or PhD degree or above in Biostatistics, Statistics, Mathematics, Computer Science, or a related field.
• 5+ years of relevant statistical programming experience using SAS; knowledge of R is a plus.
• Must have 2+ years of oncology experience in a clinical trial setting.
• Strong knowledge of CDISC standards and experience working with electronic data capture (EDC) systems such as Medidata Rave.
• Solid understanding of the drug development process and clinical trials.