United States onlyJOB SUMMARY
We are seeking a 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. This job is remote.
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
Required:
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.
Proficiency in SAS/Base, SAS/Macro, SAS/SQL, and SAS/Graph.
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.
Preferred:
Familiarity with python.
Experience in oncology clinical trials.
Exposure to cloud-based data systems or programming in a validated GxP environment.
ABOUT IAMBIC THERAPEUTICS
Founded in 2020 and headquartered in San Diego, California, Iambic Therapeutics is disrupting the therapeutics landscape with its unique AI-driven drug-discovery platform. Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters with strong track records of success in delivering clinically validated therapeutics. The Iambic platform has been demonstrated to deliver high-quality, differentiated therapeutics to clinical stage with unprecedented speed and across multiple target classes and mechanisms of action. The Iambic team is advancing an internal pipeline of clinical assets to address urgent unmet patient needs. Learn more about the Iambic team, platform, and pipeline at iambic.ai.
MISSION & CORE VALUES
Our 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.
