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. Act as the technical subject matter expert on statistical programming and mentor junior programmers. Support the preparation of clinical study reports (CSRs), regulatory submission packages (e.g., eCTD, ISS/ISE), and responses to regulatory agencies. Participate in the development and refinement of departmental processes, templates, and tools to optimize efficiency and quality. Contribute to vendor oversight and provide technical leadership when outsourcing programming activities.
QUALIFICATIONS:
Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field. Minimum of 10 years of experience in statistical programming in the pharmaceutical, biotechnology, or CRO industry. Oncology experience preferred. Proficiency in SAS/Base, SAS/Macro, SAS/SQL, and SAS/Graph. Familiarity with python 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 the ability to work both independently and as part of a cross-functional team. Exposure to cloud-based data systems or programming in a validated GxP environment preferred. ABOUT IAMBIC THERAPEUTICSIambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at iambic.ai. MISSION & CORE VALUESOur mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.
PAY AND BENEFITS:
We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.
