Senior Statistical Programmer

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🔥 10 horas atrás

🗣️🇺🇸🇬🇧 Inglês obrigatório

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WCG

1001 - 5000 funcionários

🏥 Saúde

💊 Farmacêutico

☁️ SaaS

💰 Private Equity Round - WCG em 2019-11

Healthcare • Pharmaceuticals • SaaS

A WCG é uma empresa global de serviços e tecnologia para pesquisa clínica que apoia patrocinadores, CROs, centros de pesquisa e instituições durante todo o ciclo de vida dos ensaios clínicos. Fundada como líder em revisão ética independente, a WCG fornece revisão de IRB e IBC, comitês de monitoramento de dados, capacitação de sites e serviços de iniciação de estudos, recrutamento e retenção de participantes, e dados & insights (incluindo benchmarking, consultoria estatística e previsão de ensaios impulsionada por IA). A empresa também oferece um conjunto de plataformas tecnológicas (por exemplo, ClinSphere®, eReview Manager, Total Enrollment, Total Feasibility) e grandes conjuntos de dados de protocolos e desempenho para ajudar a projetar, planejar e conduzir ensaios de forma mais eficiente e em conformidade. A WCG se posiciona como parceira de organizações de biofarma e pesquisa médica para acelerar a ativação de ensaios, melhorar o recrutamento e garantir conformidade regulatória e ética.

Descrição

• Develop, validate, and document SAS programs for clinical trial datasets (SDTM, ADaM) and outputs (tables, listings, figures) for regulatory submission, ensuring accuracy and compliance. • Lead programming activities and manage resources, timelines, and priorities for assigned studies and projects. • Conduct comprehensive quality control checks and peer code reviews on all programming deliverables. • Collaborate with statisticians, data managers, and clinical teams to ensure project requirements are met and deliverables are aligned. • Conduct thorough quality control checks on programs and datasets to ensure precision and dependability. • Oversee and manage programming activities for studies or projects, handling resource allocation, timelines, and budgets. • Guide junior programmers, offering mentorship on industry standards and best practices. • Provide expertise in interpreting and implementing Statistical Analysis Plan (SAP) programming specifications and project documentation. • Troubleshoot programming and data issues, resolve discrepancies, and ensure timely, reliable data reporting. • Coordinate multiple projects concurrently, setting strategic goals and adapting to evolving priorities. • Foster innovation within the department and contribute to process enhancement initiatives. • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

🎯 Requisitos

• At least 5 years of SAS programming experience required. • R programming experience highly preferred. • 2 years of macro programming experience required. • At least 3 years of experience in the pharmaceutical, vaccines, biotech, or medical device industry required. • Phase 1- 4 clinical trials experience. • In depth knowledge of CDISC requirements required. • Understanding of Statistical Analysis Plan programming specifications. • Attention to detail, accuracy, initiative, and excellent communication skills are essential, as well as the ability to juggle several complex tasks simultaneously.

🏖️ Benefícios

• Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts • Employee Assistance Programs and additional work/life resources • Referral Bonuses and Tuition Reimbursement • Flexible PTO • Volunteer Time Off to benefit the community • Opportunities for career development with on-the-job training, certification assistance and continuing education reimbursement

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