Senior Statistical Programmer in United States at Jobgether
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Job Description
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Statistical Programmer in United States.
This role is a key contributor within clinical development analytics, focused on transforming complex clinical trial data into high-quality, submission-ready outputs that support regulatory decision-making. You will play a central role in programming, validating, and standardizing datasets and deliverables across all phases of drug development. Working in a highly collaborative, science-driven environment, you will partner with statisticians, programmers, and clinical experts to ensure accuracy, compliance, and efficiency in reporting. The position combines deep technical SAS expertise with strong knowledge of clinical data standards such as CDISC. You will also contribute to automation and process improvement initiatives that enhance programming efficiency and quality. This is a highly impactful role supporting global drug development and regulatory submissions across diverse therapeutic areas.
- Develop and maintain SDTM and ADaM datasets, as well as Tables, Listings, and Figures (TLFs) supporting Phase I–IV clinical trials.
- Create and maintain programming specifications, annotated CRFs, Define.xml files, and reviewer guides to support regulatory submissions.
- Apply advanced SAS programming techniques, including macro development, to build scalable tools that improve programming efficiency and consistency.
- Perform quality control and validation of datasets and outputs to ensure regulatory compliance and high data integrity standards.
- Support NDA and IND submission activities by ensuring deliverables meet global regulatory expectations and documentation standards.
- Collaborate with cross-functional teams including statisticians and clinical scientists to support study-level and project-level analytics.
- Contribute to initiatives focused on automation, standardization, and improvement of statistical programming processes.
- Bachelor’s or Master’s degree in Biostatistics, Statistics, Mathematics, Life Sciences, Bioinformatics, or a related field.
- At least 6 years of experience in clinical trial statistical programming using SAS within drug development environments.
- Strong expertise in CDISC standards, including SDTM and ADaM dataset creation and implementation.
- Hands-on experience with Pinnacle 21 validation tools and Define.xml generation.
- Proven experience creating regulatory documentation, including reviewer guides and submission-ready packages.
- Solid understanding of clinical drug development and regulatory submission processes (NDA/IND experience preferred).
- Strong SAS macro programming skills; experience with R is a plus.
- Excellent attention to detail, strong organizational skills, and ability to manage multiple concurrent projects.
- Strong communication skills in English and ability to work effectively in cross-functional teams.
- Ability to work independently while maintaining high standards for quality and timely delivery.
- Competitive compensation aligned with experience and expertise.
- Opportunity to work on global clinical trials and high-impact drug development programs.
- Exposure to cutting-edge biosimulation, data science, and AI-driven life sciences innovation.
- Collaborative and science-focused work environment with cross-functional global teams.
- Professional growth opportunities through complex, regulated, and high-visibility projects.
- Flexible work arrangements depending on project and team structure.
- Inclusive and merit-based workplace culture focused on fairness and equal opportunity.