Associate Director, Statistical Programming

🕒 3 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $177.905 - $230.230 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Gilead Sciences

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1987

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

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. • Generates or oversees the production of programming deliverables (e.g., tables, listings) for study reports and integrated summaries. • Anticipates resource needs. • Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures. • Directs the design and/or coding of analysis files. • Provides primary and secondary programming support as needed and harmonizes strategic initiatives (e.g., process improvement) across a therapeutic area or equivalent. • Proven ability to create buy-in and support and has demonstrated ability to negotiate timelines. • Identifies and leads strategic initiatives for the programming group.

🎯 Requisitos

• BS degree in Biostatistics/Computer Science or equivalent and 10+ years’ experience in pharma/biotech -OR - MS degree in Biostatistics/Computer Science or equivalent and 8+ years’ experience in pharma/biotech –OR - PhD degree in Biostatistics/Computer Sciences or equivalent 3+ years of experience in pharma/biotech • Excellent verbal and written communication skills • Extensive hands-on experience with regulatory submissions including integrated analysis and post-submission activities such as FDA and PMDA filing, RtQs, AdCom preparation, and inspections • In-depth understanding of clinical programming and/or statistical programming processes and standards • Extensive experience with statistical programming using the SAS software including development and use of SAS Macros • Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)

🏖️ Benefícios

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