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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Manager, Statistical Programming (Remote) - **Company:** Penfield Search Partners - **Location:** Fairfield, CT, United States (Remote available) - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Clinical Data Management, Clinical Data Repository, Databases, Coherent Remote File System (CRFS), Data Validation, Data Presentation, R (Programming Language), Python (Programming Language), Open Source Technology, SAP (Applications), SAS (Software), Visual Analytics, Macros, Git, Information Technology, Data Management - **Published:** August 20, 2026 - **Apply:** https://www.careerjet.com/job/us1fe32ac8b2d97536161133972fb7ab24/eaa ## About the Role * Master’s degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field., * Minimum of 6 years of statistical programming experience in the pharmaceutical, biotech, or CRO clinical trial environment. * Advanced SAS and R programming skills, with experience using Git for version control required. Extensive hands-on experience with SDTM, ADaM, and TLF programming. * Python programming experience is desirable. * Proficient knowledge in the implementation of CDISC standards (SDTM, ADaM) and regulatory submission requirements. * Good knowledge of the drug development process, study design, statistical methodology, regulatory guidance, statistical concepts, and medical terminology. * Broad expertise in statistical programming and in developing computing strategies. * In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience with their implementation in clinical trials. * Knowledge of data validation, define.xml generation using Pinnacle 21. * Results-oriented, with proven problem-solving skills and a strong interest in continued learning. * Excellent communication and collaboration skills, with the ability to work closely with cross-functional teams. * Experience managing outsourced programming activities and overseeing deliverables from CROs and contractors. * Adaptable and able to thrive in a fast-paced, startup environment while managing multiple priorities effectively. * Experience with regulatory audits and inspections (e.g., FDA, PMDA, NMPA, EMA) is a strong advantage. ## Description The Senior Manager of Statistical Programming will be responsible for leading Statistical Programming activities. It involves hands-on implementation of statistical analyses using SAS/R, as well as performing quality reviews of deliverables, both for in-house analyses and outsourced programming tasks. This position serves as a critical bridge between Biostatistics and Clinical Data Management (CDM), ensuring the development of CRFs and the delivery of high-quality clinical data. Additionally, this position will play an important role in establishing SOPs and programming standards, and modernizing statistical reporting with open-source tools., Key Project Responsibilities: * Provide programming leadership and oversee study to compound-level programming deliverables in collaboration with the lead biostatistician and cross-functional teams. * Serve as the lead programmer to review the SAP, Data Presentation Plan, and Table Shells to align with project objectives and ensure clarity and completeness of programming assumptions and requirements. * Lead programming team to produce and/or validate SDTM, ADaM, and TLF for CSR and regulatory requests, publication needs, and ad-hoc analyses. * Manage CROs and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence. * Collaborate with biostatisticians and clinical development colleagues to develop/review TLF shells, SDTM, and ADaM specifications. * Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports. * Develop company tools, such as R packages, macros, and interactive data dashboards (e.g., with Shiny), to enhance the efficiency and capacity of the Statistical Programming team. * Develop robust programs to create define.xml. Lead the NDA eSubmission package preparation. Initiative Responsibilities: * Under the guidance of the Head of Statistical Programming and Compound Lead, implement innovative strategies and technologies to enhance programming processes. * Working with the manager, establish Statistical Programming standards and deploy programming strategies, specifications, and programmed analyses. * Proactively plan, implement, and identify issues/risks and provide remediation strategies to improve programming capability. ## Related Videos - [Crafting Custom Frameworks with Rust: A Deep Dive into Procedural Macros](https://www.wearedevelopers.com/videos/849-crafting-custom-frameworks-with-rust-a-deep-dive-into-procedural-macros) - [How a Small Team Shrank a Microsoft Monorepo by 94%](https://www.wearedevelopers.com/videos/1236-how-a-small-team-shrank-a-microsoft-monorepo-by-94) - [Kubernetes and Microservices with Multi-Model Databases](https://www.wearedevelopers.com/videos/382-kubernetes-and-microservices-with-multi-model-databases) - [Geometric deep learning for drug discovery](https://www.wearedevelopers.com/videos/264-geometric-deep-learning-for-drug-discovery) - [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) - [Modularity: Let's dig deeper](https://www.wearedevelopers.com/videos/1200-modularity-let-s-dig-deeper) ## Related Articles - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Best Job Boards for Remote Work for Developers](https://www.wearedevelopers.com/magazine/290-best-job-boards-for-remote-work-for-developers) - [Highest Paying Tech Companies for Developers](https://www.wearedevelopers.com/magazine/220-highest-paying-tech-companies-for-developers) - [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) - [Find a Developer Job: 12 Best Job Sites For Developers](https://www.wearedevelopers.com/magazine/165-find-a-developer-job-12-best-job-sites-for-developers) - [How Much FAANG Companies Actually Pay Software Engineers in 2025](https://www.wearedevelopers.com/magazine/230-how-much-faang-companies-actually-pay-software-engineers-in-2025)