Principal Statistical Programmer

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🔥 8 minutes ago

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🔴 Lead

🖥 Software Engineer

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

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.

📋 Description

• Meetings and communications • Generate SDTM and ADaM specifications • Generate & QC assigned dataset domains • Support submission activities • Generate TLFs (patient profile, interim analysis, annual summary report, final CSR) • Prepare SDTM define files and reviewer guide(s) and ADaM define files and reviewer guide(s) • Handling Data transfers to sponsor (or other designee) • Publication support • Ad hoc tasks/activities requested by sponsor • Writing SAS macros and other utilities and tools • Reviewing documents/specifications/output created by sponsor’s Partner CROs • Maintenance of associated tracking and validation documentation

🎯 Requirements

• At a minimum bachelor’s degree in computer science, data science, mathematics, or statistics major preferred • 8+ years of experience as a Statistical Programmer in clinical Development environment • Excellent SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment • Extensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation • Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities • Prior working experience with Oncology studies • Must be able to work independently • Outstanding communication skills (written and verbal) and strong leadership skills

🏖️ Benefits

• Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support.