Senior Principal Statistical Programmer

JOB SUMMARY

We are seeking a Senior Principal Statistical Programmer to join our Clinical Development team at Iambic. This role will be a key contributor in supporting statistical programming activities for clinical trials, from Phase I through regulatory submission. The ideal candidate is a hands-on leader with deep technical expertise in SAS programming and CDISC standards, as well as a strong understanding of regulatory requirements and clinical trial processes. Additionally, this role will interface with the data science and machine learning groups and provide collaboration efforts to bridge clinical and existing AI infrastructure.

KEY RESPONSIBILITIES

• Lead the design, development, validation, and maintenance of SAS programs for the generation of SDTM, ADaM, and TLFs (tables, listings, and figures).

• Ensure compliance with CDISC standards (SDTM and ADaM), FDA/EMA regulatory guidelines, and internal SOPs.

• Collaborate closely with Biostatisticians, Data Managers, and Clinical Operations teams to define programming requirements and timelines.

• Perform quality control and peer review of deliverables to ensure accuracy, consistency, and adherence to specifications.

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