Senior/Principal Statistical Programming

🔥 6 minutes ago

🇬🇧 United Kingdom – Remote

⏳ Contract/Temporary

🟠 Senior

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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.

📋 Description

• Serve as a lead statistical programmer for multiple studies and/or compounds • Lead and execute statistical programming activities across clinical trials from study start-up through database lock, reporting, and regulatory submission • Ensure consistency, quality, and timely delivery of programming deliverables • Support global regulatory submissions and responses to health authority questions • Provide technical oversight and guidance for outsourced statistical programming activities • Develop, review, and validate tables, listings, figures (TLFs), SDTM/ADaM datasets, and Define-XML documentation • Develop, QC/validate, and document SAS programs • Contribute to SAS programming standards, SOPs, work instructions, and best practices • Maintain study-related programming documentation in accordance with Ipsen processes and keep it inspection/audit ready • Collaborate with statisticians, clinical teams, data management, and cross-functional stakeholders • Provide technical guidance and mentoring to other statistical programmers • Identify process improvements and support complex study design methodologies • Act as a statistical programming subject matter expert and contribute to technical decision-making

🎯 Requirements

• Strong proficiency in SAS programming within a pharmaceutical, biotechnology, or CRO environment • Strong understanding of CDISC standards, including SDTM and ADaM • Hands-on experience with SDTM and ADaM specification, development, and programming • Strong experience in TFL programming and reporting • Experience supporting clinical trial reporting and/or regulatory submissions • Experience working with complex clinical trial data and study designs • Ability to provide technical leadership and independently manage programming activities across multiple studies • 8+ years of statistical programming experience in a pharmaceutical, biotechnology, or CRO environment supporting clinical development • Bachelor or MSc in Statistics, Mathematics, or Scientific Discipline • English • Experience in Oncology, Rare Disease, or Neuroscience preferred • R or other packages desired • Experience in NDA/sNDA submission desired • French preferred

🏖️ Benefits

• Security and additional career opportunities through working for a global CRO • Continuous training and development • Close management and training • Equal opportunity employer committed to diversity and inclusivity