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Iambic Therapeutics, a clinical-stage life-science and technology company developing novel medicines using an AI-driven discovery and development platform, is seeking a Senior Principal Statistical Programmer to join the Clinical Development team. This is a hands-on technical leadership role supporting statistical programming activities for clinical trials from Phase I through regulatory submission.
You will lead the design, development, validation, and maintenance of SAS programs for generating SDTM, ADaM, and TLFs (tables, listings, and figures). You will ensure compliance with CDISC standards (SDTM and ADaM), FDA/EMA regulatory guidelines, and internal SOPs. Key responsibilities include collaborating with Biostatisticians, Data Managers, and Clinical Operations teams to define programming requirements; performing quality control and peer review of deliverables; acting as the technical subject matter expert on statistical programming and mentoring junior programmers; supporting preparation of clinical study reports (CSRs) and regulatory submission packages (e.g., eCTD, ISS/ISE); participating in the development of departmental processes, templates, and tools; and providing technical leadership for vendor oversight and outsourced programming activities.
You will also interface with the data science and machine learning groups to bridge clinical and AI infrastructure efforts. This role offers the opportunity to work at the intersection of clinical development and cutting-edge AI technology in a company that has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed.
QUALIFICATIONS:
- Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or related field
- Minimum 10 years of experience in statistical programming in pharmaceutical, biotechnology, or CRO industry (oncology experience preferred)
- Proficiency in SAS/Base, SAS/Macro, SAS/SQL, and SAS/Graph (Python familiarity preferred)
- Strong experience with CDISC standards (SDTM and ADaM) and familiarity with define.xml and Pinnacle 21
- Experience supporting regulatory submissions to FDA and/or EMA
- Excellent problem-solving skills, attention to detail, and ability to work independently and cross-functionally
- Exposure to cloud-based data systems or programming in validated GxP environment preferred
