About this role
Principal Statistician - Permanent Role -Remote in UK
ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.
We are seeking a highly skilled Principal Statistician to lead statistical activities for clinical trials. This role requires hands-on statistical expertise, strong communication skills, and the ability to independently lead projects while collaborating closely with cross-functional teams.
Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
Key Responsibilities
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Lead and provide statistical support for clinical studies.
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Act as the lead statistician on assigned studies, overseeing statistical strategy and deliverables
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Author and review key statistical documents, including:
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Statistical Analysis Plans (SAPs)
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Analysis Database Specifications (ADS)
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Statistical sections of clinical study reports
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Review and interpret analysis outputs, ensuring accuracy, quality, and regulatory compliance
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Collaborate with cross-functional teams including Clinical, Programming, Data Management, and Regulatory
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Provide guidance and oversight to statistical programmers as needed
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Communicate statistical concepts, results, and risks clearly to both technical and non-technical stakeholders
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Ensure adherence to regulatory standards (FDA, ICH, GCP) and company SOPs
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Required Qualifications
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MS or PhD in Statistics, Biostatistics, or a related field
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There are no specific therapeutic area requirements; however, experience in Oncology, Rare Disease, or Neuroscience would be advantageous.
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Strong oral and written communication skills, with the ability to effectively communicate internally and with clients.
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Demonstrated understanding and insight in statistics, drug development process, and relevant FDA regulations.
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Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially the FDA.