Senior Statistical Programmer – FSP

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🕒 5 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🖥 Engenheiro de Software

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Clinical Outcomes Solutions

SiteLinkedInTodas as Vagas

51 - 200 funcionários

💼 Consultoria

🏥 Saúde

🧬 Biotecnologia

Consulting • Healthcare • Biotechnology

A Clinical Outcomes Solutions é uma consultoria global de desfechos clínicos que oferece suporte e serviços abrangentes em todos os aspectos da pesquisa de Avaliação de Desfecho Clínico (COA). A empresa ajuda a informar o cuidado ao paciente capturando a voz do paciente por meio de métodos científicos inovadores. Ela orienta as organizações a navegar nas complexidades da pesquisa de desfechos clínicos, elaborando estratégias e soluções para capturar dados precisos. Confiada por empresas farmacêuticas e biotecnológicas, a empresa garante conformidade regulatória e otimização dos resultados dos pacientes.

Descrição

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming • Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs) • Production and QC / validation programming • Generating complex ad-hoc reports utilizing raw data • Applying strong understanding/experience of Efficacy analysis • Creating and reviewing submission documents and eCRTs • Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries • Performing lead duties when called upon • Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc. • Being adaptable and flexible when priorities change

🎯 Requisitos

• Bachelor’s degree in one of the following fields Statistics, Computer Science, Mathematics, etc. • At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above. • Study lead experience, preferably juggling multiple projects simultaneously preferred. • Strong SAS data manipulation, analysis and reporting skills. • Solid experience implementing the latest CDISC SDTM / ADaM standards. • Strong QC / validation skills. • Good ad-hoc reporting skills. • Proficiency in Efficacy analysis. • Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. • Submissions experience utilizing define.xml and other submission documents. • Experience supporting immunology, respiratory or oncology studies would be a plus. • Excellent analytical & troubleshooting skills. • Ability to provide quality output and deliverables, in adherence with challenging timelines. • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.

🏖️ Benefícios

• We believe in applying scientific rigor to reveal the full promise inherent in data. • We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery. • We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities. • We prize innovation and seek intelligent solutions using leading-edge technology.