Join Iambic Therapeutics as a Senior Principal Statistical Programmer to lead statistical programming for clinical trials in a remote role.
Posted by employer 7 hours ago
First seen on Joblaze 2 hours ago
Last verified on the company career page 2 hours ago
What you'll build
Must have
Nice to have
AI in the day-to-day
Interface with data science and machine learning groups to bridge clinical and existing AI infrastructure.
Requirements
Not disclosed in this posting: compensation, visa sponsorship.
Benefits
Joblaze summary
The Senior Principal Statistical Programmer at Iambic Therapeutics plays a crucial role in leading statistical programming efforts for clinical trials, ensuring compliance with regulatory standards and CDISC guidelines. This position requires extensive experience in SAS programming, particularly in generating SDTM and ADaM datasets, along with a solid understanding of clinical trial processes. Ideal candidates will have over a decade of experience in the pharmaceutical or biotechnology sectors, with oncology expertise being a plus. The role also involves collaboration with cross-functional teams and mentoring junior programmers, contributing to a culture of innovation within a rapidly growin
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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
MISSION & CORE VALUES
PAY AND BENEFITS
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