
Principal Biostatistician, FSP
Posted 19 hours ago

Posted 19 hours ago
This is a fully remote position, open to applicants in India, +1 more country.
• Lead statistical initiatives for assigned Clinical Trials (Phases 1 to 4) from protocol design through to the reporting of results, independently.
• Serve as the representative for the Statistics function on cross-functional trial teams and possibly indication/project teams.
• Collaborate efficiently with all cross-functional stakeholders.
• Supervise internal programming tasks and/or contributions from CROs on assigned clinical studies.
• Contribute to or take a lead role in Safety Reporting, ISS/ISE, responses to Health Authorities, and Publications.
• Utilize SAS and/or R for quality control of datasets and deliverables, perform inferential statistical analyses, modeling/simulation, and exploratory analyses.
• Participate in initiatives at Cytel or from the sponsor's perspective.
• Provide guidance and oversight to junior Statisticians.
• Develop integrated analytical strategies employing statistical methods, machine learning, and deep learning algorithms to unearth actionable insights and automate repetitive processes.
• A minimum of a Bachelor's degree in statistics or a related field.
• Over 9 years of experience supporting clinical trials within the Pharmaceutical or Biotechnology sectors.
• Capability to work independently, showing initiative and adaptability through effective and innovative leadership.
• Strong attention to detail and commitment to quality, alongside excellent interpersonal and communication skills, innovative thinking, and collaborative behavior.
• Proficiency in SAS programming for quality control of critical outputs, efficacy/safety tables, and close collaboration with Programmers.
• Familiarity with R programming (R Shiny/Python).
• Ongoing training, development, and support.
• Opportunities for significant professional growth.
• Autonomy and ownership over your work.
• Support from Cytel while working closely with a pharmaceutical client.
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