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.
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.
