Principal Biostatistician, FSP

This is a fully remote position, open to applicants in United States.

📋 Description

• Independently lead statistical activities for assigned Phase I–IV clinical trials, from protocol design through to the reporting of results.

• Act as the Statistics function representative on cross-functional trial, indication, or project teams.

• Collaborate effectively with cross-functional stakeholders.

• Supervise internal programming activities and/or contributions from CROs.

• Contribute to or take the lead on statistical activities, including safety reporting, ISS/ISE, Health Authority inquiries, and publications.

• Utilize SAS and/or R for quality control of datasets and deliverables, perform inferential statistical analyses, conduct modeling/simulation, and execute exploratory analyses.

• Engage in initiatives at Cytel or on the sponsor side.

• Provide oversight to junior statisticians as necessary.

• Offer statistical and developmental support for clinical trials, processes, clinical development plans, concept sheets, and protocols.

• Develop integrated analytical strategies using various data sources, statistical methods, machine learning, and deep learning algorithms.

⛳️ Requirements

• 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 autonomously and exhibit initiative and adaptability through effective, innovative leadership.

• Strong attention to detail and a commitment to quality.

• Excellent interpersonal and communication abilities.

• Demonstrated innovative and collaborative behaviors.

• Proficiency in SAS programming for quality checking critical outputs, efficacy/safety tables, and collaboration with programming teams.

• Familiarity with R programming, R Shiny, or Python.

• Solid technical understanding of appropriate clinical-trial data analysis, in line with ICH E9 guidelines.

• Experience in representing the biostatistics function and collaborating across various functions.

• Strong communication skills.

• Willingness to engage in self-directed learning and perform tasks with minimal supervision.

🏝️ Benefits

• Ongoing training, development, and support.

• Ample opportunities for professional growth.

• Full integration with support from Cytel.

• A sense of autonomy and ownership in your work.