Senior Principal Statistical Programmer

Iambic Therapeutics

. Lead the design, development, validation, and maintenance of SAS programs generating SDTM, ADaM, and TLFs .

Posted 9/29/2026full-timeRemote • United StatesSenior💰 $152,000 - $190,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical programming with a strong focus on SAS, CDISC standards, and regulatory submissions. Proven ability to lead programming efforts, mentor junior staff, and collaborate effectively across clinical and data science teams.

Highest-signal resume keywords

SAS/Base ProficiencyCDISC Standards ExpertiseRegulatory Submission ExperienceStatistical Programming LeadershipOncology Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

SAS/MacroSAS/SQLSAS/GraphStatistical ProgrammingQuality ControlData ManagementClinical Trial SupportRegulatory ComplianceProblem-SolvingAttention to Detail

Soft Skills

CollaborationMentoringIndependent WorkCross-Functional Teamwork

Tools & Technologies

Define.xmlPinnacle 21Cloud-Based Data SystemsValidated GxP Environment

Industry Keywords

Pharmaceutical IndustryBiotechnologyCRO IndustryFDA GuidelinesEMA GuidelinesSDTMADaMECTDISS/ISEOncology

Tech Stack

Tools & technologies

CloudPythonSQL

About the role

Key responsibilities & impact

Lead the design, development, validation, and maintenance of SAS programs generating SDTM, ADaM, and TLFs
Ensure compliance with CDISC standards, FDA/EMA regulatory guidelines, and internal SOPs
Collaborate with Biostatisticians, Data Managers, and Clinical Operations teams to define programming requirements and timelines
Perform quality control and peer review of deliverables
Act as the technical subject matter expert on statistical programming
Mentor junior programmers
Support preparation of clinical study reports, regulatory submission packages including eCTD and ISS/ISE, and responses to regulatory agencies
Develop and refine departmental processes, templates, and tools
Contribute to vendor oversight and provide technical leadership for outsourced programming activities
Interface and collaborate with data science and machine learning groups to bridge clinical and AI infrastructure
Support statistical programming activities for clinical trials from Phase I through regulatory submission

Requirements

What you’ll need

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)
Familiarity with define.xml and Pinnacle 21
Experience supporting regulatory submissions to FDA and/or EMA
Excellent problem-solving skills and attention to detail
Ability to work independently and as part of a cross-functional team
Exposure to cloud-based data systems or programming in a validated GxP environment preferred
Currently authorized to work in the United States
Must answer whether visa sponsorship will be required now or in the future

Benefits

Comp & perks

Company-paid healthcare
Flexible spending accounts
Voluntary life insurance
401K matching
Uncapped vacation
Onsite gym
Onsite dining
Brand-new state-of-the-art facility