Senior Principal Statistical Programmer

🕒 Agosto 14

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $144.400 - $189.400 / ano

⏰ Tempo Integral

🟠 Sênior

🖥 Engenheiro de Software

👻 Score fantasma 1%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of BeOne Medicines

BeOne Medicines

10.000+ funcionários

Fundada em 2010

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

Biotechnology • Healthcare • Pharmaceuticals

A BeOne Medicines é uma empresa global de oncologia, com sede na Suíça, que descobre e desenvolve tratamentos inovadores mais acessíveis e com maior disponibilidade para pacientes com câncer em todo o mundo. Com um portfólio que abrange hematologia e tumores sólidos, a BeOne está acelerando o desenvolvimento de seu diversificado pipeline de novas terapias por meio de capacidades internas e colaborações. Com uma equipe global em crescimento, formada por mais de 11.000 colaboradores presentes em seis continentes, a empresa está comprometida em melhorar radicalmente o acesso a medicamentos para muito mais pacientes que deles precisam.

Descrição

• Technically lead and project manage multiple clinical studies and their statistical and clinical programming deliverables • Represent Statistical Programming in Study Management Team and Clinical Development meetings • Assess resourcing needs and support project staffing • Review study-related documents including statistical analysis plans, case report forms, data management plans, database specifications, EDC data structures, and DMC plans • Collaborate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing, and other partners • Write, test, and validate SAS programs producing analysis datasets, tables, listings, graphs, and presentation outputs • Execute and develop department-, product-, and study-level macros and utilities • Provide technical guidance on complex programming tasks and standards • Contribute to Statistical Programming policies, standard operating procedures, and controlled documents • Interface with outsourcing partners and vendors

🎯 Requisitos

• Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or another relevant scientific subject, or equivalent related experience • Minimum 5+ years of clinical research and development programming experience using SAS • Expert-level SAS programming experience delivering complex programming assignments and analyses • Knowledge of SDTM and ADaM standards • Experience writing CDISC-standard dataset specifications • Experience creating SDTM and ADaM datasets from specifications • Ability to develop, test, and validate analysis datasets, tables, listings, graphs, macros, utilities, and presentation outputs • Expert-level knowledge and extensive hands-on experience with CDISC methodologies • Experience leading or working with centralized Statistical Programming teams • Experience in oncology trials • Experience with FDA, EMEA, and CFDA clinical trial and regulatory submissions • Experience with the drug development process in preclinical, early, late-stage, and/or observational settings • Knowledge of drug development fundamentals and project planning and management • Excellent verbal and written communication skills • Ability to collaborate effectively in a dynamic environment

🏖️ Benefícios

• Annual bonus plan eligibility for Non-Commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness

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