10 дней назад
Senior/Principal Statistical Programmer (Clinical Statistical Programming)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior/Principal Statistical Programmer (Clinical Statistical Programming): Leading statistical programming across clinical trials and supporting regulatory submissions with an accent on SAS, CDISC standards, SDTM/ADaM datasets, and TLF reporting. Focus on validating complex programming deliverables, overseeing outsourced activities, and providing technical guidance across Oncology, Rare Disease, or Neuroscience studies.
Location: Remote in the United Kingdom
Company
is a global full-service contract research organization providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
What you will do
- Lead statistical programming activities across multiple clinical studies and compounds from study start-up through database lock, reporting, and regulatory submission.
- Develop, review, and validate tables, listings, figures, SDTM and ADaM datasets, Define-XML, and related documentation.
- Provide technical oversight for outsourced programming activities and ensure delivery quality, timelines, and compliance.
- Collaborate with statisticians, clinical teams, data management, and other stakeholders to translate complex study designs and endpoints into programming solutions.
- Maintain programming standards, SOPs, work instructions, and inspection-ready documentation.
- Mentor statistical programmers and act as a subject matter expert for technical decisions and continuous improvement.
Requirements
- English required for communication and collaboration.
- 8+ years of statistical programming experience in a pharmaceutical, biotechnology, or CRO environment.
- Strong SAS programming expertise, including development, quality control, validation, and documentation.
- Strong knowledge of CDISC standards and hands-on experience with SDTM and ADaM specification, development, and programming.
- Experience with TFL programming, clinical trial reporting, regulatory submissions, and complex clinical trial data.
- Bachelor’s or MSc degree in Statistics, Mathematics, or another scientific discipline.
Nice to have
- Experience in Oncology, Rare Disease, or Neuroscience.
- Experience with R or other statistical programming packages.
- Experience with NDA or sNDA submissions.
- French language skills.
Culture & Benefits
- Work directly for a single sponsor while receiving the career opportunities and security of a global CRO.
- Work remotely from the United Kingdom.
- Access to continuous training and development focused on technical competence and client processes.
- Collaborate within a diverse organization of more than 4,000 professionals across over 20 countries.
- Opportunities are expected to become available throughout 2027 based on client demand and business growth.
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