Job Title: Principal Biostatistician FSP
Location: Remote (United Kingdom, Germany, France, Spain)
Job Type: Full-time
Posted: Feb. 4, 2025
Job ID: 415
Job Overview:
As a Principal Biostatistician at Cytel, you will be dedicated to a major pharmaceutical client, providing statistical leadership and expertise in the development and analysis of clinical trials, with a particular focus on late-phase studies and regulatory submissions. You will leverage your experience in drug development, especially within Gastrointestinal studies, to drive clinical innovation and support the development of new treatments.
Responsibilities:
Lead statistical teams on clinical development projects, ensuring timely delivery of statistical output aligned with project goals.
Provide statistical input into clinical development plans, protocols, case report forms (CRFs), and data management plans.
Contribute to the preparation of statistical analysis plans (SAPs), perform statistical analyses, and review regulatory submission dossiers.
Manage biostatisticians and statistical programmers on a project, guiding the team on statistical strategy, deliverables, and processes.
Collaborate with cross-functional teams to ensure project goals are met, including working closely with regulatory authorities for electronic submissions.
Develop sourcing strategies for projects and maintain strong communication with sponsor biostatistics management.
Qualifications:
Education: Master’s degree in Statistics or related discipline (Ph.D. strongly preferred).
Experience: 6+ years supporting clinical trials in the pharmaceutical or biotechnology industry.
At least 3 years of recent experience with late-phase (II & III) drug development, including drafting SAPs, calculating sample size, and reviewing TLFs.
Experience with Gastrointestinal studies or regulatory submissions is a plus.
Strong SAS and/or R programming skills for QCing critical outputs, efficacy/safety tables, and collaborating with programmers.
Leadership experience in managing biostatisticians and statistical programmers.
Ability to work independently, innovate, and provide leadership in a team environment.
Excellent interpersonal, communication, and collaboration skills.
Additional Information:
Location: Remote work available in the United Kingdom, Germany, France, or Spain.
Cytel offers opportunities for professional development and growth, fostering an innovative work environment.
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