Senior Statistical Programmer

Vaga não está no LinkedIn

🕒 Setembro 15

🇦🇷 Argentina – Remoto

⏰ Tempo Integral

🟠 Sênior

🖥 Engenheiro de Software

👻 Score fantasma 19%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

Candidatar-se

Encontrar Vagas Remotas Similares

Innovaderm Research Inc.

SiteLinkedInTodas as Vagas

201 - 500 funcionários

💊 Farmacêutico

🏥 Saúde

💼 Consultoria

Pharmaceuticals • Healthcare • Consulting

Como uma CRO (Organização de Pesquisa por Contrato) especializada em dermatologia, fornecemos orientação científica, resultados precisos e satisfação do cliente. Nossa oferta de serviços única combina Serviços de Pesquisa Contratual especializados, conhecimento de locais de dermatologia na América do Norte e Europa e as capacidades ampliadas de um grande site de pesquisa clínica.

Descrição

• Lead single and/or multiple clinical trials as a Senior Statistical Programmer. • Develop, maintain, and validate annotated Case Report Forms (aCRFs). • Develop and maintain specifications and perform statistical programming for SDTM datasets, ADaM datasets or derived datasets, Tables, Listings, and Figures (TLFs). • Prepare submission packages for Data Monitoring Committee (DMC) reviews, Interim Analyses (IAs), Clinical Study Reports (CSRs), and other purposes. • Review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and Data Management documents such as eCRFs and edit checks. • Support data cleaning activities by programming, reporting, reviewing, and closing statistical data issues. • Develop and validate SDTM and ADaM define.XML/PDF files and reviewer guides. • Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21. • Use global SAS macros to improve statistical programming efficiency. • Act as an Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and interim analyses. • Collaborate with Biostatistical study teams and cross-functional departments to deliver high-quality work within timelines and budget. • Mentor junior Statistical Programmers as needed. • Participate in internal initiatives involving standard macros, templates, programming standards, and processes. • Keep current with industry, CDISC, ICH, and regulatory standards and requirements.

🎯 Requisitos

• Bachelor’s degree in Statistics, Computing Sciences or a related field; master’s degree an asset. • At least 5 years of clinical research experience in biotechnology, pharmaceutical or Contract Research Organization (CRO) industry, including 4 years of Statistical Programming and 1 year acting as a Lead Statistical Programmer. • Excellent exposure to clinical trial data, SAP, TLF Shells, and specifications. • Excellent working knowledge of SAS; SAS certification an asset. • Knowledge of XML programming an asset. • Excellent working knowledge of CDISC standards and guideline; CDISC certification an asset. • Excellent knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP. • Very organized and detail-oriented, with effective project planning and time management skills. • Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands. • Must be able to work independently and as part of a team. • Strong verbal and written communication skills in English; French an asset. • Must be legally able to work in Argentina.

🏖️ Benefícios

• Permanent full-time position • Flexible schedule • Home-based position • Ongoing learning and development • Attractive advancement opportunities • Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo