Job Title: Principal Biostatistician FSP
Location: Remote USA
Job Type: Full-time
Posted: Feb. 13, 2025
Job ID: 440
Position Overview:
As a Principal Biostatistician, you will be embedded with one of Cytel’s pharmaceutical clients, providing statistical leadership for clinical trials, especially focusing on late-phase trials and regulatory submissions in Gastrointestinal studies. Your role will involve leading statistical teams, contributing to clinical development plans, protocols, and regulatory submissions, and employing advanced statistical techniques like machine learning to derive actionable insights.
Responsibilities:
Provide statistical leadership for clinical development projects, including input on development plans, concept sheets, and protocols.
Lead statistical teams to ensure timely delivery of statistical outputs across clinical trials.
Draft and review statistical analysis plans (SAPs), sample size calculations, and efficacy/safety tables (TLFs).
Contribute to study protocols, case report forms, and data management plans.
Lead regulatory submissions, including contributing to clinical study reports and regulatory dossiers.
Manage biostatisticians and statistical programmers, ensuring alignment of statistical strategies.
Foster collaboration with cross-functional teams and biostatistics management.
Qualifications:
Education: Master’s degree in Statistics or a related discipline. Ph.D. is strongly preferred.
Experience:
6+ years of experience supporting clinical trials in the pharmaceutical/biotechnology industry.
At least 3 years of recent experience in late-phase drug development (II & III), including drafting SAPs and reviewing TLFs.
Experience in leading statistical teams and managing projects.
Experience with Gastrointestinal studies or regulatory submissions is a plus.
Skills:
Strong SAS and/or R programming skills for statistical analyses.
Knowledge of the pharmaceutical industry and regulatory environment.
Additional Information:
Location: Remote position, based in Cambridge, MA, USA.
Cytel’s Values: Cytel values collaboration, innovation, and the application of cutting-edge technology in clinical development.
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Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
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Auckland |New Zealand :
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Vienna |Catalonia :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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