Senior Principal Statistical Programmer

Emploi pas sur LinkedIn

🕒 il y a 10 jours

🌲 North Carolina – Distant

🌲 North Carolina – Remote

💵 $131 100 - $160 000 / an

⏰ Temps Plein

🟠 Senior

🖥 Ingénieur Logiciel

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WCG

Site WebLinkedInTous les Emplois

1001 - 5000 employés

🏥 Santé

💊 Pharmaceutique

☁️ SaaS

💰 Private Equity Round - WCG en 2019-11

Healthcare • Pharmaceuticals • SaaS

WCG est une entreprise mondiale de services de recherche clinique et de technologies qui soutient les promoteurs, les CRO, les sites de recherche et les institutions à travers le cycle de vie des essais cliniques. Fondée en tant que leader dans l'évaluation éthique indépendante, WCG fournit des examens IRB et IBC, des comités de surveillance des données, des services de facilitation de sites et de démarrage d'études, de recrutement et de fidélisation des participants, ainsi que des données et insights (y compris l'étalonnage, le conseil statistique et la prévision d'essais alimentée par l'IA). L'entreprise propose également une suite de plateformes technologiques (par exemple, ClinSphere®, eReview Manager, Total Enrollment, Total Feasibility) et de grands ensembles de données de protocoles et de performances pour aider à concevoir, planifier et mener des essais de manière plus efficace et conforme. WCG se positionne comme un partenaire des organisations biopharmaceutiques et de recherche médicale pour accélérer l'activation des essais, améliorer l'inscription et assurer la conformité réglementaire et éthique.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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