Senior Principal Statistical Programmer

Job not on LinkedIn

🔥 9 minutes ago

🇺🇸 United States – Remote

💵 $152k - $190k / year

⏰ Full Time

🟠 Senior

🖥 Software Engineer

👻 Ghost score 3%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Iambic Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 Series B on 2024-04

Healthcare • Consulting • Manufacturing

Iambic Therapeutics is a pioneering biotechnology company that leverages advanced AI algorithms for drug discovery. Their innovative, high-throughput experimental platform aims to address unmet patient needs by optimizing molecules for various therapeutic targets. The company's AI-driven approach allows it to rapidly explore chemical spaces, revealing novel drug mechanisms and delivering high-quality leads at an accelerated pace compared to traditional methods.

📋 Description

• 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

• 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

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