Senior Principal Statistical Programmer

Iambic; San Diego (CA); On-site; USD 152,000 - 190,000; Full time

Benefits offered by this job

Competitive pay

Company healthcare

401K matching

Uncapped vacation

Onsite gym

Job summary

Iambic Therapeutics in San Diego, CA, seeks a Senior Principal Statistical Programmer to lead SAS programming for SDTM/ADaM, from Phase I through regulatory submissions.

The ideal candidate brings hands-on leadership, deep SAS expertise, CDISC standards mastery, and a track record with regulatory submissions to FDA/EMA, while collaborating with data science and AI teams.

Join a cross-functional team advancing an AI-driven discovery platform in a fast-paced, GxP environment.

Qualifications

• Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field.
• Minimum of 10 years of statistical programming experience in pharma/biotech/CRO.
• Proficiency in SAS/Base, SAS/Macro, SAS/SQL, SAS/Graph; Python familiarity.
• Strong CDISC SDTM/ADaM experience; define.xml and Pinnacle 21 familiarity.
• Experience supporting regulatory submissions to FDA/EMA.
• Excellent problem-solving and cross-functional team collaboration.

Responsibilities

• Lead design, development, validation, and maintenance of SAS programs for SDTM, ADaM, and TLFs.
• Ensure CDISC standards compliance and adherence to FDA/EMA guidelines.
• Collaborate with Biostatisticians, Data Managers, and Clinical Operations to define requirements and timelines.
• Perform QC and peer reviews of deliverables for accuracy and consistency.
• Act as SME on statistical programming and mentor junior programmers.
• Support preparation of CSRs, submissions (eCTD, ISS/ISE), and regulatory responses.
• Contribute to development and refinement of processes, templates, and tools.
• Provide technical leadership in vendor oversight during external programming work.

Skills

SAS programming

CDISC standards

Regulatory submissions

Education

Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or related field

Tools

SAS/Base

SAS/Macro

SAS/SQL

SAS/Graph

Job description

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.

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 Therapeutics

Iambic 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 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.

Compensation Range: $152K - $190K