Principal Statistical Programmer

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🔥 18 horas atrás

🏄 California – Remoto

🏄 California – Remote

⏰ Tempo Integral

🔴 Especialista

🖥 Engenheiro de Software

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Clinical Outcomes Solutions

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Clinical Outcomes Solutions é uma consultoria global de desfechos clínicos que oferece suporte e serviços abrangentes em todos os aspectos da pesquisa de Avaliação de Desfecho Clínico (COA). A empresa ajuda a informar o cuidado ao paciente capturando a voz do paciente por meio de métodos científicos inovadores. Ela orienta as organizações a navegar nas complexidades da pesquisa de desfechos clínicos, elaborando estratégias e soluções para capturar dados precisos. Confiada por empresas farmacêuticas e biotecnológicas, a empresa garante conformidade regulatória e otimização dos resultados dos pacientes.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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