Senior Manager, Statistical Programming

🕒 Agosto 13

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $153.935 - $199.210 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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Gilead Sciences

SiteLinkedInTodas as Vagas

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

• Work collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting • Serve as project leader • Generate or oversee programming deliverables, including tables and listings, for study reports and integrated summaries • Interact within Biometrics, Clinical Data Science, Clinical Development, and Regulatory Affairs groups • Anticipate resource needs and work with management and HR on long-term resource allocation within a therapeutic project • Inform functional management of programming resources required for projects • Manage a small team of programmers, including FTEs and contractors • Design and/or code analysis files • Ensure programming and documentation follow departmental procedures • Be responsible for programming activities within a therapeutic project or equivalent • Provide primary and secondary programming support as needed • Implement strategic initiatives • Define and produce user-defined statistical reports and ad hoc requests • Resolve study-related issues and conflicts within a therapeutic project • Negotiate timelines and create buy-in and support • Directly supervise personnel and perform task or performance management as required • Participate in cross-functional meetings as a Programming representative • Represent the Company on contracts when applicable • Recommend and provide trainings • Create inclusion, develop talent, and empower teams as a people leader

🎯 Requisitos

• 8 years of experience and a BS degree in Biostatistics/Computer Science or equivalent • 6 years of experience and an MS degree in Biostatistics/Computer Science or equivalent • 0 years of experience and a PhD degree in Biostatistics/Computer Sciences or equivalent • Advanced degree in Biostatistics/Computer Science or equivalent preferred • 8+ years of pharmaceutical/CRO experience preferred • Prior experience in oncology, hematology, or cell therapy strongly preferred • Hands-on experience in pivotal studies and/or regulatory submissions, including NDA, BLA, and MAA • In-depth understanding of clinical programming and/or statistical programming processes and standards • In-depth understanding of regulatory requirements relevant to statistical programming, including GCP and ICH • Extensive experience with statistical programming using SAS, including development and use of SAS Macros • Advanced knowledge of CDISC standards, including CDASH, SDTM, and ADaM • Proven experience leading programming activities • Excellent verbal and written communication, interpersonal, problem-solving, and analytical skills • Thorough understanding of clinical trial design and reporting processes, regulatory reporting requirements, and electronic data submissions • Ability to interact with others to define and produce user-defined statistical reports • Ability to resolve study-related issues and conflicts • Ability to negotiate timelines and create buy-in and support • Ability to directly supervise personnel; performance or task management may be required

🏖️ Benefícios

• Discretionary annual bonus eligibility • Discretionary stock-based long-term incentives eligibility may vary based on role • Paid time off • Company-sponsored medical insurance • Company-sponsored dental insurance • Company-sponsored vision insurance • Company-sponsored life insurance • Benefits package