5 дней назад
Principal Statistician (Clinical Trials)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Principal Statistician (Clinical Trials): Leading statistical activities and deliverables for clinical studies with an accent on statistical strategy, analysis documentation, and regulatory compliance. Focus on authoring SAPs and clinical study report sections, interpreting analysis outputs, and coordinating statistical work across clinical, programming, data management, and regulatory teams.
Location: Remote in the United Kingdom
Company
is a global full-service contract research organization supporting clinical development for pharmaceutical, biotechnology, medical device, and consumer health companies.
What you will do
- Lead statistical support and statistical strategy for assigned clinical studies.
- Author and review Statistical Analysis Plans, Analysis Database Specifications, and statistical sections of clinical study reports.
- Review and interpret analysis outputs to ensure accuracy, quality, and regulatory compliance.
- Collaborate with Clinical, Programming, Data Management, and Regulatory teams.
- Provide guidance and oversight to statistical programmers.
- Communicate statistical concepts, results, and risks to technical and non-technical stakeholders.
Requirements
- MS or PhD in Statistics, Biostatistics, or a related field.
- Strong understanding of statistics, the drug development process, and relevant FDA regulations.
- Industry experience in pharmaceuticals, CROs, or related fields involving clinical trials.
- Experience interacting with regulatory agencies, especially the FDA.
- Strong oral and written communication skills and the ability to lead projects independently.
- Compliance with FDA, ICH, GCP, and company SOP standards.
Nice to have
- Experience in Oncology, Rare Disease, or Neuroscience.
Culture & Benefits
- Permanent remote role for candidates based in the United Kingdom.
- Professional growth supported through continuous training and development.
- One-team, quality-driven culture with cross-functional collaboration.
- Work supporting clinical development and the delivery of innovative drugs and devices.
- Diversity and inclusion are core company values.
Hiring process
- CV submission is followed by an application acknowledgement.
- Selected candidates are invited to a phone interview as the first step.
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