Senior Principal Statistical Programmer - Remote

3 days ago

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ClinChoice

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ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

Full-Service CRO • Clinical Development • Post-Marketing & Real-World Evidence • Quality and Compliance • Technology

1001 - 5000 employees

Founded 1998

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Programming edit checks for Data Management with SAS. • Create tables, listings and figures for clinical study report. • Independently annotated blank CRF (acrf.pdf) with appropriate tools per FDA or CDISC guidelines. • Create or QC SDTM specifications and SDTM datasets. • Create or QC ADaM specifications and ADaM datasets. • Create or QC define.xml or define.pdf. • Create Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf). • Serve as team leader for one or more Programming groups. • Independently coordinate and manage the preparation, execution, reporting and documentation of projects within a Programming group. • Manage and coordinate the integration of data across studies in support if ISS and ISE and electronic submission deliverables. • Following industry standards and be a mentor to other Programming leads or managers. • Manage programming team. Take initiatives and follow through to develop the Programming team. Dare to lead. • Be a role model for team members.

🎯 Requirements

• Bachelor’s degree in computer science, statistics or related scientific disciplines with 10+ year clinical programming experience; Master’s degree in computer science, statistics or related disciplines with 9+ year of clinical programming experience. • Working knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology • Good understanding of clinical drug development process. • Detail oriented. • Strong communication skills and coordination skills. • Good leadership skills.