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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Manager, Statistical Programming - **Company:** Kardigan, Inc. - **Location:** Princeton, NJ, United States - **Experience:** Expert - **Salary:** $172,000.0 - $234,000.0 - **Contract:** Permanent contract - **Skills:** Biometrics, Clinical Data Management, Clinical Data Repository, Databases, Coherent Remote File System (CRFS), Data Validation, Data Presentation, Graphical User Interface, SAP (Applications), SAS (Software), Computational Statistics, Macros, Information Technology, Data Management - **Published:** May 19, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=c2b60098edd96949 ## About the Role * Master's degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field., * Minimum of 6 years statistical programming experience in the pharmaceutical, biotech or CRO clinical trial environment. * Advanced SAS programming skills. Extensive Hands-on experience with SDTM, ADaM, TLF programming * Proficient knowledge in the implementation of CDISC standards (SDTM, ADaM) and regulatory submission requirements. * Good knowledge of 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 of their implementation in clinical trials. * Demonstrated proficiency in using SAS/R to produce analysis datasets and TFLs. * Knowledge of data validation, define.xml generation using Pinnacle 21. * Results orientated with proven problem-solving skills and a strong interest in ongoing 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 thrives in a fast-paced, startup environment while managing multiple priorities effectively. * Experience with regulatory audits and inspections and IR (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 helping establish SOPs and programming standards and also build our SCE platform., Key Project Responsibilities: * Provides programming leadership and oversee study to compound-level programming deliverable in collaboration with the Stats lead and cross-functional teams. * Serve as the lead programmer to reviews SAP, Data Presentation Plan, Table Shell to align with project objectives and ensures 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 global tools, such as macros or graphical user interface applications, to enhance the efficiency and capacity of the Statistical Programming team. * Develops robust program to create define.xml, Leads the NDA eSubmission package preparation. * Assist Biometric in building the statistical computing environment (SCE) platform, including designing folder structure and managing access control. Initiative Responsibilities: * Under guidance from Head of Statistical Programming and Compound PL, implement innovative strategies and technologies to enhance programming processes. * Working with manager, establish Statistical Programming standard and deploy programming strategies, specifications and programmed analysis. * Proactively plan, implement, and identify issues/risks and provide remediation strategies to improve programming capability. ## Related Videos - [Data Science on Software Data](https://www.wearedevelopers.com/videos/162-data-science-on-software-data) - [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) - [Kubernetes and Microservices with Multi-Model Databases](https://www.wearedevelopers.com/videos/382-kubernetes-and-microservices-with-multi-model-databases) - [Biometric Phone Chargers, $40m Domain Names & AI Movies Winning Awards - Peter Kröner](https://www.wearedevelopers.com/videos/1810-biometric-phone-chargers-40m-domain-names-ai-movies-winning-awards-peter-kroner) - [Modularity: Let's dig deeper](https://www.wearedevelopers.com/videos/1200-modularity-let-s-dig-deeper) - [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 - [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) - [Data Analyst Salary in the UK](https://www.wearedevelopers.com/magazine/278-data-analyst-salary-in-the-uk) - [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) - [The Most Popular IT Jobs on the Market](https://www.wearedevelopers.com/magazine/376-the-most-popular-it-jobs-on-the-market) - [Quick guide: How to write a Software Developer CV](https://www.wearedevelopers.com/magazine/37-quick-guide-how-to-write-a-software-developer-cv)