Senior/Principal Statistical Programmer, FSP, SAS, R

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🌐 Poland, Estonia, +3 more countries – Remote

🇵🇱 Poland – Remote 🇪🇪 Estonia – Remote 🇪🇸 Spain – Remote 🇿🇦 South Africa – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

🖥 Software Engineer

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and Define.xml files for multiple studies • Develop SAS programs generating datasets, complex listings, tables, descriptive and inferential statistics, and complex graphs • Develop, validate, and maintain SAS and/or R programs for clinical development programs • Oversee CRO statistical programming deliverables across multiple clinical studies • Support clinical study reports, regulatory submissions, publications, annual DSURs, and exploratory analyses • Follow FDA regulations, good clinical practice, and electronic submission guidelines • Create, maintain, document, and validate programming tools, outputs, macros, and standards • Participate in CRF development, edit check specifications, and data validation plans • Review or author data transfer specifications for external vendor data • Collaborate with CROs, software vendors, clinical development partners, and internal functions to meet timelines and goals • Review or author SOPs and work instructions related to statistical programming

🎯 Requirements

• At minimum, a bachelor’s degree in computer science, data science, mathematics, or statistics; statistics major preferred • 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar team • Experience supporting drug development, medical device development, or intervention studies • Exceptional SAS programming skills and expertise developing and implementing statistical programming procedures and processes in a clinical development environment • Hands-on R programming experience • Extensive applied experience with CDISC standards, including SDTM, ADaM, and Define.xml • Knowledge of medical terminology, clinical trial methodologies, and FDA/ICH regulations • Experience supporting regulatory submissions and interacting with the FDA and/or global regulatory authorities • Ability to work independently • Outstanding written and verbal communication skills and strong leadership skills • Preferred: pharmacokinetic data and neuroscience experience • Preferred: proficiency in additional tools or languages such as Python, Java, Shiny, Markdown, Unix/Linux, and git

🏖️ Benefits

• Consistent training, development and support • Significant professional growth opportunities • Cytel support while working fully embedded within a pharmaceutical client