Senior Statistical Programmer

🕒 Abril 1

🔔 Pennsylvania, Washington – Remoto

🔔 Pennsylvania – Remote ☕ Washington – Remote

⏰ Tempo Integral

🟠 Sênior

🖥 Engenheiro de Software

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ClinChoice

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1998

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

ClinChoice é uma organização global de pesquisa contratada (CRO) de serviço completo, estabelecida em 1995, especializada em desenvolvimento clínico, pós-comercialização e suporte a serviços funcionais para as indústrias farmacêutica, biotecnológica e de dispositivos médicos. Eles oferecem soluções abrangentes desde o desenvolvimento clínico inicial até a gestão do ciclo de vida pós-aprovação, com expertise em diversas áreas terapêuticas, como autoimunidade e inflamação, dermatologia, endocrinologia, doenças infecciosas, neurociência e oncologia. ClinChoice visa contribuir para um mundo mais saudável e seguro, acelerando o desenvolvimento e a comercialização de medicamentos e dispositivos inovadores. A empresa apoia seus clientes com expertise clínica, regulatória e operacional em todas as fases do desenvolvimento de produtos.

Descrição

• Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. • Develop SDTM specifications and generate SDTM datasets using SAS. • Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan. • Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts. • Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). • Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision. • Analyze information and develop innovative solutions to programming and data analysis challenges. • Actively communicate with statisticians for statistical input and analysis interpretation. • Follow and reinforce regulatory agency requirements during daily job. • Serve as a programming team lead and contribute to department initiative. • Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams. • Review draft and final production deliverables for project to ensure quality and consistency.

🎯 Requisitos

• Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 3 years of clinical programming experience. • Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. • Database programming experience is a plus. • Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. • Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world. • In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology. • Good understanding of clinical drug development process. • Strong communication skills and coordination skills. • Detail-oriented and ability to learn and adapt to changes. • Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.

🏖️ Benefícios

• Employees can work remotely