Job Title: Senior SAS Programmer
Location: Remote
Experience: 7+ Years
Job Summary:
We are seeking a highly skilled Senior SAS Programmer to support the statistical programming activities for clinical trials. This role involves end-to-end SAS programming for analysis and reporting, with a focus on regulatory compliance, data standards, and high-quality deliverables. The ideal candidate should have strong experience in efficacy analysis, SDTM and ADaM generation, and TLF programming.
Key Responsibilities
* Lead the development, validation, and maintenance of SAS programs to support clinical trial data management, analysis, and regulatory submissions.
* Generate and QC datasets (SDTM, ADaM), Tables, Listings, and Figures (TLFs) in compliance with study protocols and CDISC standards.
* Collaborate directly with medics, scientists, and statisticians to translate scientific requirements into accurate programming deliverables.
* Review and provide input to study protocols, CRFs, and statistical analysis plans (SAPs).
* Perform advanced statistical programming tasks, ensuring compliance with FDA/EMA/ICH regulatory guidelines.
* Mentor and guide junior programmers, ensuring best practices and high-quality deliverables.
* Support ISS/ISE preparation and other submission-related activities.
* Provide technical expertise for troubleshooting, process improvements, and automation initiatives.
* Communicate complex data insights effectively to medical and scientific stakeholders.
Qualifications
* Bachelor’s or Master’s degree in Life Sciences, Statistics, Computer Science, or a related field (medical/scientific background preferred).
* 6–10 years of hands-on experience in SAS programming within the pharmaceutical, biotechnology, or CRO industry.
* Strong knowledge of clinical trial data, CDISC standards (SDTM, ADaM), and regulatory submission requirements.
* Expertise in Base SAS, SAS/STAT, SAS Macro programming.
* Proven ability to collaborate with cross-functional teams, especially medics and scientists.
* Strong leadership, problem-solving, and communication skills.
* Prior experience in mentoring or leading programming teams is a plus.