> Markdown version of [/jobs/ext/2986376-principal-statistical-programmer](https://www.wearedevelopers.com/jobs/ext/2986376-principal-statistical-programmer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Principal Statistical Programmer - **Company:** Katalyst Talent Agency - **Location:** Edison, NJ, United States - **Contract:** Permanent contract - **Skills:** Microsoft Access, Data Analysis, Clinical Data Repository, Databases, Coherent Remote File System (CRFS), Electronic Signatures, SAS (Software), SAS/Base, SAS/STAT, SQL Databases, Utility Software, Information Technology, Programming Languages - **Published:** September 18, 2026 - **Apply:** https://www.careerjet.com/job/us9195aff707273bfdab51fabd9ec819cf/eaa ## About the Role * Must have expertise in SAS/BASE, SAS/STAT, and knowledge of SAS/CONNECT, SAS/ACCESS, SAS/MACRO, SAS/GRAPH, SQL, and ODS * Knowledge of SDTM, ADaM, FDA and ICH guidance * Understanding of Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records and electronic signatures in computer systems. * Good organizational skills across individual projects and managing own and teamwork loads. Ability to organize, manage and complete multiple assignments with challenging timelines independently and effectively. * Consistent experience as a lead statistical programmer on several concurrent projects * Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions * Strong mentoring skills as shown by leadership of projects and if applicable, junior team members. * Excellent analytical skills * Proven ability to learn new systems and function in an evolving technical environment. * Ability to negotiate and influence to achieve results. * Good presentation skills * Good business awareness/business development skills (including financial awareness) * Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial. * Work effectively in a quality-focused environment. * Knowledge of other programming languages and database management software packages is a plus. ## Description * Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs. * Be responsible for overall project delivery, including clinical trial reports and other regulatory submission deliverables. * Create statistical analysis outputs to be used in support of final reports, abstracts, posters, Manu scripts and other clinical publications; support systems to produce electronic regulatory submissions. * Assist in establishing standardized programming procedures and work instructions. * Develop, enhance, evaluate, and validate standardized macros and utility programs to ensure that regulatory requirements are met through validation/compliance activities. * Develop and maintain clinical processing workflow systems. * Assist in the development of client proposal documents. * Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities. * Provide input into and negotiate statistical programming timelines. Ensure that timelines are adhered to and coordinate and lead a statistical programming team to successful completion of a study within given timelines and budgets. * Trained in sponsor SOPs and disseminate knowledge to project team members as appropriate. * Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) * records handling (e.g., Chapter 21 of the US Code of Federal Regulation - Part 11), and electronic submission of clinical data to agencies (e.g., e-CTD guidance and CDISC SDTM and ADaM standards) * Assist in updating/writing PROMETRIKA standard operating procedures (SOPs) * Develop tools in SAS® for data analysis and reporting that comply with regulatory requirements. * Develop specifications (e.g., metadata files), annotate CRFs and create SAS® programs for the mapping of raw datasets to CDISC SDTM standards. * Create define.xml files from metadata files for SDTM and ADaM * Convert data received in other formats to SAS® datasets. ## Related Videos - [Kubernetes and Microservices with Multi-Model Databases](https://www.wearedevelopers.com/videos/382-kubernetes-and-microservices-with-multi-model-databases) - [Data Science on Software Data](https://www.wearedevelopers.com/videos/162-data-science-on-software-data) - [Fault Tolerance and Consistency at Scale: Harnessing the Power of Distributed SQL Databases](https://www.wearedevelopers.com/videos/1146-fault-tolerance-and-consistency-at-scale-harnessing-the-power-of-distributed-sql-databases) - [Grappling With Clunky Old Software? Start by Understanding What’s Inside!](https://www.wearedevelopers.com/videos/1189-grappling-with-clunky-old-software-start-by-understanding-what-s-inside) - [How I saved 200K/yr in direct costs writing 0 code lines in K8s](https://www.wearedevelopers.com/videos/1055-how-i-saved-200k-yr-in-direct-costs-writing-0-code-lines-in-k8s) - [Branch your database like your code: How schema changes and pull requests go hand in hand](https://www.wearedevelopers.com/videos/350-branch-your-database-like-your-code-how-schema-changes-and-pull-requests-go-hand-in-hand) ## Related Articles - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers) - [Highest Paying Tech Companies for Developers](https://www.wearedevelopers.com/magazine/220-highest-paying-tech-companies-for-developers) - [Data Analyst Salary in the UK](https://www.wearedevelopers.com/magazine/278-data-analyst-salary-in-the-uk) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [React Developer Salary [2023]](https://www.wearedevelopers.com/magazine/198-react-developer-salary-2023) - [7 Important Tips That Every Software Developer Should Know](https://www.wearedevelopers.com/magazine/101-7-important-tips-that-every-software-developer-should-know)