Principal Statistical Programmer – Functional Service Provider

hace 6 días

Madrid, España Kelly Science, Engineering, Technology & Telecom A tiempo completo

Principal Statistical Programmer – Functional Service Provider (FSP) Engagements Join to apply for the Principal Statistical Programmer – Functional Service Provider (FSP) Engagements role at Kelly Science, Engineering, Technology & Telecom.Contract: 12 months with possible extension.Are you ready to take your statistical programming career to the next level? Join us as a Principal Statistical Programmer where you’ll play a key technical and strategic role across multiple clinical studies and post-marketing projects. You'll work hands‑on with advanced analytical techniques, lead programming efforts, and collaborate with cross‑functional industry leaders to deliver high‑quality results that support patient safety, drug efficacy, and regulatory success.What You'll Do Lead Statistical Programming: Be the main programming expert for assigned studies, working closely with sponsors and internal teams to drive project success.Develop Reliable Analyses: Create and validate SAS programs for analysis datasets (ADaM), tables, listings, and figures that underpin clinical study reports, interim analyses, and exploratory data reviews.Champion Quality and Compliance: Review and oversee statistical deliverables from external partners to ensure accuracy and regulatory alignment.Shape Regulatory Submissions: Prepare submission‑ready documentation (define.xml, annotated CRFs, Reviewer’s Guides), and collaborate on pooled analyses for integrated safety & efficacy summaries.Collaborate and Communicate: Work alongside biostatistics, data management, and medical writing teams to meet project timelines and deliverables.Promote Process Improvement: Streamline and automate workflows using tools like R, Python, or metadata frameworks.Mentor and Inspire: Support junior programmers, fostering growth in statistical programming and data analytics.Ensure Audit Readiness: Maintain top‑quality documentation and compliance with industry standards and best practices.Who You Are Experienced Programmer: Master’s degree (7+ years) or Bachelor’s (9+ years) in Statistics, Computer Science, or a related field, with hands‑on experience in clinical trial statistical programming.CDISC Expert: Deep knowledge of SDTM and ADaM standards and submission processes.Analytical Leader: Proven ability to handle ad‑hoc and exploratory analyses, and support publication and regulatory responses.Collaborator: Strong communication skills and experience leading projects and managing deliverables from external providers.Tech‑Savvy: Experience with Pinnacle 21, Define.xml, and data visualization platforms (Spotfire, R Shiny) is a plus.Innovator: Familiarity with R or Python for automation and statistical programming is highly desirable.Why Apply? Here, you’ll have the chance to make a meaningful impact, mentor others, and innovate in a dynamic and supportive environment. If you’re ready to lead, collaborate, and help shape the future of clinical research, we want to hear from youSeniority Level Mid‑Senior levelEmployment Type Full‑timeJob Function Information TechnologyLocation Madrid, Community of Madrid, Spain#J-18808-Ljbffr

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