Senior Principal Statistical Programmer — SAS/CDISC Leader

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

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.