Senior Principal Statistical Programmer

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🔥 10 horas atrás

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

💵 $131.100 - $160.000 / ano

⏰ Tempo Integral

🟠 Sênior

🖥 Engenheiro de Software

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WCG

SiteLinkedInTodas as Vagas

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

• Serve as a senior technical expert in statistical programming, providing guidance across multiple studies or functional areas. • Design, develop, validate, and oversee complex statistical programming deliverables, including analysis datasets, tables, listings, and figures. • Lead the development, validation, and continuous improvement of DMC macros and programming standards. • Provide technical oversight and review of programming work to ensure quality, compliance, and consistency across deliverables. • Drive the establishment and adoption of programming standards, best practices, and process improvements. • Collaborate with biostatistics and study teams to support complex trial designs, analyses, and DMC reporting. • Independently manage and prioritize programming activities across multiple studies or initiatives. • Mentor and provide technical leadership to statistical programming staff, supporting skill development and best practices. • Contribute technical expertise to proposals, project planning, and scope discussions as needed. • Partner with IT and technology teams to support SAS environments, tools, and system validation efforts. • Provide technical oversight for programming activities supporting regulatory submissions and inspection readiness. • Ensure programming deliverables align with regulatory expectations, submission requirements, and CDISC standards. • Influence programming approaches, standards, and best practices across multiple studies or programs. • Serve as a technical escalation point for complex programming, data, or deliverable issues, leading resolution of highly complex or ambiguous challenges. • Provide expert interpretation of statistical analysis plans (SAPs), protocols, and study documents, translating requirements into programming strategy. • Champion process improvements, automation, and innovative approaches to enhance efficiency, scalability, and consistency of programming deliverables. • Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.

🎯 Requisitos

• Minimum 8–10 years of statistical programming experience in a clinical trial environment • Deep expertise in SAS programming, including complex analyses and regulatory deliverables • Proficiency in R programming is a must • Demonstrated experience with CDISC standards and regulatory requirements • Proven ability to independently lead complex programming efforts across studies • Experience mentoring staff and driving technical standards or best practices • Demonstrated ability to independently coordinate biostatistical projects, including planning and oversight of programming activities, with minimal direction from senior leadership.

🏖️ 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