Senior Statistical Programmer, SAS, R

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🌐 Poland, United Kingdom, +4 more countries – Remote

🇵🇱 Poland – Remote 🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote 🇿🇦 South Africa – Remote 🇷🇴 Romania – Remote 🇪🇪 Estonia – 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/R programs generating datasets, complex listings, tables, and 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 standards for programming tools, outputs, and macros • Participate in developing CRFs, edit check specifications, and data validation plans • Review and/or author data transfer specifications for external vendor data • Collaborate with CROs, software vendors, clinical development partners, and internal functions to meet project timelines and goals • Review and/or author SOPs and work instructions related to statistical programming practices • Track progress and provide expert technical support to team members • Implement reporting and analysis activities for Sponsor clinical trials

🎯 Requirements

• At a minimum, bachelor’s degree in computer science, data science, mathematics, or statistics • 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 in clinical development programming procedures and processes • Extensive applied experience with CDISC standards, including SDTM, ADaM, and Define.xml • Knowledge of medical terminology and clinical trial methodologies • Knowledge of 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 • Strong leadership skills • Preferred: pharmacokinetic data and neuroscience experience • Preferred: proficiency in R, Python, Java, Shiny, Markdown, Unix/Linux, and git • Good R experience stated in the internal qualifications

🏖️ Benefits

• Consistent training, development and support • Significant professional growth • Working fully embedded within a pharmaceutical client with Cytel support