Principal Statistical Programmer

Position Overview

• Location Type: Remote
• Job Type: Full-Time
• Salary: $148K - $190K

Iambic is seeking a Principal Statistical Programmer to join its Clinical Development team. This role is crucial for supporting statistical programming activities across all phases of clinical trials, from Phase I to regulatory submission. The ideal candidate will be a hands-on leader with extensive SAS programming expertise, a deep understanding of CDISC standards, regulatory requirements, and clinical trial processes. This position will also involve collaboration with data science and machine learning groups to integrate clinical data with existing AI infrastructure.

Key Responsibilities

• Lead the design, development, validation, and maintenance of SAS programs for generating SDTM, ADaM, and TLFs (tables, listings, and figures).
• Ensure adherence to CDISC standards (SDTM and ADaM), FDA/EMA regulatory guidelines, and internal SOPs.
• Collaborate with Biostatisticians, Data Managers, and Clinical Operations teams to define programming requirements and timelines.
• Conduct quality control and peer review of deliverables to ensure accuracy, consistency, and adherence to specifications.
• Serve as the technical subject matter expert in 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 enhancement of departmental processes, templates, and tools to improve efficiency and quality.
• Contribute to vendor oversight and provide technical leadership for outsourced 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 within 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 independently and collaboratively within 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 leveraging a unique AI-driven drug-discovery platform to transform the therapeutics landscape. The company has assembled a world-class team of AI experts and experienced drug hunters with proven track records in developing clinically validated therapeutics. Iambic's platform is designed to deliver high-quality, differentiated therapeutics to the clinical stage rapidly and across various target classes and mechanisms of action. The company is advancing an internal pipeline of clinical assets to address critical unmet patient needs. Learn more at iambic.ai.

Mission & Core Values

Iambic's mission is to deliver better medicines through innovations in AI-based discovery technologies. The company fosters a culture that is significantly strengthened by the diversity of its people, including differences in background, culture, national origin, religion, sexual orientation, and life experiences. Iambic is committed to building an inclusive environment where a diverse group of talented individuals collaborate to discover therapeutics and create technologies.

Pay and Benefits

Iambic offers industry-leading competitive pay, company-paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation time.