Lead SAS Programmer — CDISC & AI Collaboration

Iambic Therapeutics, Inc

San Diego (CA)

On-site

USD 140,000 - 180,000

Full time

8 days ago
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Job summary

Iambic Therapeutics, Inc. is seeking a Senior Principal Statistical Programmer to join our Clinical Development team in San Diego. The role leads SAS programming for SDTM, ADaM and TLFs across trials from Phase I through regulatory submission, ensuring CDISC compliance and regulatory alignment.

The ideal candidate is a hands-on leader with deep SAS expertise, CDISC standards knowledge, and experience supporting FDA/EMA submissions, while collaborating with data science and AI groups.

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 pharma/biotech/CRO; oncology preferred.
  • Proficiency in SAS/Base, SAS/Macro, SAS/SQL, and SAS/Graph; Python preferred.
  • Strong experience with CDISC standards (SDTM/ADaM) and familiarity with define.xml and Pinnacle 21.
  • Experience supporting regulatory submissions to FDA/EMA.

Responsibilities

  • Lead the design, development, validation, and maintenance of SAS programs for SDTM, ADaM, and TLFs.
  • Ensure compliance with CDISC standards and regulatory guidelines.
  • Collaborate with Biostatisticians, Data Managers, and Clinical Operations to define requirements and timelines.
  • Perform QC and peer review of deliverables to ensure accuracy and quality.
  • Mentor junior programmers and act as SME for statistical programming.
  • Support CSR preparation and regulatory submission packages (eCTD, ISS/ISE).
  • Contribute to development of processes, templates, and tools; oversee outsourced programming.

Skills

Problem solving
Attention to detail
Independence
Cross-functional collaboration
Mentoring

Education

Bachelor's or Master's in CS/Statistics/Math/Life Sciences

Tools

SAS/Base
SAS/Macro
SAS/SQL
SAS/Graph
Python
CDISC SDTM/ADaM
define.xml
Pinnacle 21

Job description

Iambic Therapeutics, Inc. is seeking a Senior Principal Statistical Programmer to join our Clinical Development team in San Diego. The role leads SAS programming for SDTM, ADaM and TLFs across trials from Phase I through regulatory submission, ensuring CDISC compliance and regulatory alignment.

The ideal candidate is a hands-on leader with deep SAS expertise, CDISC standards knowledge, and experience supporting FDA/EMA submissions, while collaborating with data science and AI groups.

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