Statistical Programmer II

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🕒 Maio 15

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $107.185 - $138.710 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🖥 Engenheiro de Software

🚫👨‍🎓 Sem graduação necessária

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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 • Assesses the quality and consistency of analysis data and performs cross-study analyses • Uses internal macros or writes SAS® macros to automate study deliverables • Assists in submissions of electronic data (e.g., SAS® data sets) to regulatory agencies • Has sufficient understanding to follow an analysis plan and provide programming support for study deliverables • Assists in the review of GSI Policies, SOPs and other controlled documents • Provides input to and participates in Programming and Clinical Data Science meetings • Contributes to the continuous improvement of Programming Environment • Demonstrates SAS programming proficiency • Generates the production of statistical analysis datasets and outputs (e.g., tables, figures, and listings) for study reports and integrated summaries • Has knowledge of clinical trial study design and electronic data submission requirements • Assists with study and systems audits, and responds to audit questions and findings • Collaborates with Biostatisticians, Clinical Data Management, and Clinical Research Scientists on studies and helps define the data set

🎯 Requisitos

• Master’s and 2 years of relevant experience OR Bachelor’s and 4 years of relevant experience • Degree in Biostatistics/Computer Science or equivalent (preferred) • 5+ years of pharmaceutical/CRO experience (preferred) • Prior experience in oncology, hematology, cell therapy 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.) (preferred) • 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 and R software including development and use of SAS Macros, R Packages • Experience with development of CDISC standardized ADaM datasets and specifications • Advanced knowledge in SDTM domains • Proven experience in leading programming activities • Excellent interpersonal, communication, problem solving, and analytical skills. • Willing to handle multiple projects and ad-hoc tasks

🏖️ 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