Senior Statistical Programmer

Emploi pas sur LinkedIn

🕒 il y a 10 jours

🌲 North Carolina – Distant

🌲 North Carolina – Remote

💵 $104 750 - $128 000 / 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

• 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.

🎯 Exigences

• 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.

🏖️ 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