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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Manager, Statistical Programming - **Company:** ONE STOP COLLECTIBLE CORP - **Location:** South San Francisco, CA, United States - **Experience:** Expert - **Salary:** $172,000.0 - $234,000.0 - **Contract:** Permanent contract - **Skills:** Databases, Data Validation, R (Programming Language), Python (Programming Language), SAS (Software), Git, Information Technology - **Published:** September 4, 2026 - **Apply:** https://startup.jobs/senior-manager-statistical-programming-kardigan-8110177 ## 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 - [Kubernetes and Microservices with Multi-Model Databases](https://www.wearedevelopers.com/videos/382-kubernetes-and-microservices-with-multi-model-databases) - [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) - [Times of (climate) crisis - How and why sustainable software is a must!](https://www.wearedevelopers.com/videos/988-times-of-climate-crisis-how-and-why-sustainable-software-is-a-must) - [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) - [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) ## Related Articles - [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) - [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) - [10 Highest Paying Programming Languages 2025](https://www.wearedevelopers.com/magazine/150-10-highest-paying-programming-languages-2025) - [Data Science & more: The Lopez dilemma](https://www.wearedevelopers.com/magazine/10-data-science-more-the-lopez-dilemma) - [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer)