Principal Statistical Programmer, Oncology

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October 7

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Clinical Outcomes Solutions

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Biotechnology • Pharmaceuticals • Healthcare Insurance

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.

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies • Develop SAS programs which generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs • Deliver high-quality statistical programming results including developing, validating, and maintaining SAS and/or R programs tailored to clinical development programs’ needs • Support the preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses

🎯 Requirements

• At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred • 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar team and experience supporting drug development, medical device development, or intervention studies • Must be able to work independently • Experience in oncology studies using RECIST 1.1.

🏖️ Benefits

• Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation • Exceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment • Outstanding communication skills (written and verbal) and strong leadership skills