Principal / Associate Director, Statistical Programming
Core
Lead and support statistical programming activities across multiple clinical studies to ensure high-quality data analysis and regulatory submissions for MASH therapeutics.
Role type
Senior IC statistical programmer with leadership responsibilities
Builds
Regulatory submission packages (NDA/BLA), clinical trial analysis datasets, and automated programming tools
Domain
Biopharmaceuticals / Clinical Data Management / Statistical Programming
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SAS programming and macro development, CDISC standards (SDTM, ADaM), regulatory submission experience, CRO partner management, statistical concepts, process automation
Preferred skills
R programming, NDA/BLA submission experience, Define.xml validation, pooled analysis
Technologies
SAS, R, Define.xml
Responsibilities
Develop and validate SAS programs for data transformation and reporting; Review CRO deliverables including SDTM, ADaM, and TLFs; Collaborate with biostatistics and clinical teams on data usage; Support regulatory submissions and integrated safety/efficacy summaries; Maintain programming standards, macros, and SOPs; Lead process improvement and automation initiatives
Seniority
Senior, hands-on IC with leadership duties
