Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward.
We are hiring a remote Principal Statistician to lead and support statistical activities for multiple clinical studies, participating in protocol development and executions, ensuring compliance with SOPs to produce quality and timely statistical deliverables. This position reports to the Sr. Director, Biostatistics.
Key Responsibilities
- Serve as a study biostatistician for multiple clinical studies
- Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
- Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells... for tables, figures and listings
- Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
- Provide statistical input to data monitoring committee (DMC) charters, project management plans, and other study-level documents
- Work with statistical programmers or CROs to generate tables, figures and listings
- Support ongoing safety review and DMC review of the clinical development program/study teams
- Perform ad hoc and exploratory statistical analyses as needed
- Contribute to clinical study reports, including authoring of statistical sections, interpretation of the study results, and QC of the results in the reports.
- Support regulatory submissions as needed
- Support the preparation of publications, including manuscripts, posters and oral presentations
- Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs
About You
- MS in biostatistics or equivalent with at least 7 years of relevant clinical trial experience or PhD in biostatistics or equivalent with at least 5 years relevant clinical trial experience.
- Knowledge of statistical methods for clinical trials
- Knowledge in Rare Diseases or gene therapies is not required.
- Proficient in statistical programming (SAS is required, and R is a plus)
- Good communication skills and ability to work with cross-functional study teams
- Ability to multi-task in an extremely fast-paced environment with changing priorities
- Ability to solve analytical/technical problems
- Positive, outgoing and collaborative attitude
Job Segment: Developer, Statistics, Project Manager, Technology, Data, Research
