Senior Statistical Programmer – CDISC Lead

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🕒 September 22

🌐 Spain, Portugal, +1 more countries – Remote

🇪🇸 Spain – Remote 🇵🇹 Portugal – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

👻 Ghost score 22%

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📋 Description

• Lead and contribute to development, review, and documentation of CDISC-compliant dataset specifications and datasets, focusing on SDTM and ADaM • Serve as a subject matter expert for CDISC standards governance • Perform quality control of CDISC dataset specifications, derived datasets, and standard or custom TFLs • Generate or review TFLs for clinical study reports and regulatory submissions • Perform statistical programming using SAS and R • Prepare submission-ready regulatory documentation, including Define.xml, SDRG, ADRG, ISS/ISE, and related materials • Contribute to process optimization, SAS macro libraries, code and documentation templates, SOPs, R adoption, automation, AI integration, and training development • Provide technical support and training to team members • Collaborate with statisticians and Data Management to resolve and document data issues • Participate in task forces and initiatives • Validate and debug code written by other team members • Coordinate preparation, execution, reporting, and documentation of statistical programming activities internally and externally • Maintain project quality and timeliness

🎯 Requirements

• Master's degree in Statistics, Biostatistics, Data Science, or a related quantitative field with 6+ years of experience; or Bachelor's degree in the same fields with 8+ years of experience • 6+ years of clinical statistical programming experience with a master's degree, or 8+ years with a bachelor's degree, within the pharmaceutical, biotechnology, or CRO industry • Demonstrable hands-on regulatory submission work • Expert-level proficiency in CDISC-compliant statistical programming in SAS • Experience developing SDTM and ADaM datasets from raw clinical data • Strong understanding of CDISC Implementation Guides (SDTMIG, ADaMIG) • Experience supporting eCTD regulatory submissions, including SDTM/ADaM datasets, Define.xml, SDRG, ADRG, TFLs, and submission documentation aligned with FDA and EMA expectations • Experience creating macro libraries, format catalogs, enhanced visual output displays, training presentations, SOPs, and other documentation • Excellent organizational, project management, written and verbal communication skills • Ability to work with internal and external stakeholders and build partnerships • Comfortable working across multiple phases of clinical development • Ability to manage multiple projects and meet deadlines in a fast-paced environment • Advanced SAS programming skills • Proficiency or active development in R is strongly preferred • Strong understanding of clinical trial design, data analysis, and regulatory requirements • Excellent problem-solving skills and attention to detail • Strong communication and interpersonal skills, with ability to guide diverse groups through complex processes • Experience with SDSP, SDRG, or ADRG as primary author beyond execution-level contribution is preferred • Experience with cross-study data integration, SEND, international remote teams, management, Agile/scrum, or statistical background is preferred or a plus

🏖️ Benefits

• Benefit offerings outside the US may vary by country and will be aligned to local market practice • Equal employment opportunity and reasonable accommodation support

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