Manager, Statistical Programming

🕒 Julho 22

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $133.195 - $172.370 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of Gilead Sciences

Gilead Sciences

10.000+ funcionários

Fundada em 1987

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

Descrição da empresa: No Gilead, estabelecemos – e atingimos – ambições audaciosas para criar um mundo mais saudável para todas as pessoas. Desde nossos medicamentos pioneiros em virologia até nosso crescente impacto em oncologia, estamos entregando inovações que antes eram consideradas impossíveis na medicina. Nosso foco vai além dos medicamentos, e também nos esforçamos para corrigir desigualdades em saúde e eliminar barreiras ao acesso aos cuidados. Capacitamos nossos colaboradores para enfrentar esses desafios, e estamos todos unidos em nosso compromisso de ajudar milhões de pessoas a viverem vidas mais saudáveis.

Descrição

• Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting• Serves as project leader• Generates or oversees the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries• Successfully interacts within Biometrics, with Clinical Development and Regulatory Affairs groups on a frequent basis• Actively share experience and discuss possible process enhancements at programming meetings• Recommends potential trainings• Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures• Responsible for all programming activities within a therapeutic project or equivalent• Implements strategic initiatives• Able to lead and manage multiple concurrent projects

🎯 Requisitos

• Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience• Degree in Biostatistics/Computer Science or equivalent• 6+ years of pharmaceutical/CRO experience• Prior experience in oncology, hematology, and cell therapy is strongly preferred• Knowledge of long term follow up trial knowledge strongly preferred• Hands-on experience in pivotal studies and/or regulatory submissions (NDA, BLA, MAA, etc.)• In-depth understanding of clinical programming and/or statistical programming processes and standards• In-depth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH)• Extensive experience with statistical programming using the SAS software including development and use of SAS Macros• Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)• Proven experience in leading programming activities

🏖️ Benefícios

• company-sponsored medical, dental, vision, and life insurance plans• discretionary annual bonus• discretionary stock-based long-term incentives (eligibility may vary based on role)• paid time off

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