Principal Statistical Programmer – Oncology

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🌐 United Kingdom, South Africa, +1 more countries – Remote

🇬🇧 United Kingdom – Remote 🇿🇦 South Africa – Remote 🇪🇸 Spain – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

👻 Ghost score 22%

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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

• Work independently with concept-level instruction and very little supervision • Track progress and provide expert technical support to team members • Work on clinical development programs across different therapeutic areas • Oversee CRO programmers to ensure consistent, high-quality data summaries • Implement reporting and analysis activities for sponsor clinical trials • Generate SDTM and ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies • Develop SAS 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 CRF, edit check specification and data validation plan development • Review or author data transfer specifications for external vendor data • Collaborate with CROs, software vendors and clinical development partners to meet timelines and goals • Review or author SOPs and work instructions related to statistical programming

🎯 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 • Experience in oncology endpoints and analyses • Exceptional SAS programming skills • Extensive applied experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation • 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 • Proficiency in other languages or tools such as R, Python, Java, Shiny, Markdown, Unix/Linux and git is preferred

🏖️ Benefits

• Consistent training, development and support • Significant professional growth • Meaningful work and stimulating challenges • Welcoming and diverse global culture