Senior Biostatistician- Oncology Late-Phase Trials / Cell Therapy (Remote, EU)

As a leader in next generation, data-driven pharmaceutical services, Cytel is shaping the future of clinical development. We deliver to the market high impact statistical consultancy on clinical development plans and individual trials, innovative analytical software for statistical analysis and simulation, and best-in-class data science analytics services. Our culture is inclusive, collaborative and results-driven with a shared commitment to quality. With operations across North America, Europe, and India, Cytel hires passionate and talented people who share its mission of ensuring the development of safe and effective health technologies.

We are hiring a remote Senior Biostatistician experienced in supporting late-phase Oncology trials to support cell therapy (CAR T) studies.  Position is remote and can work from Switzerland, UK, Germany and Spain.

Summary of Job Responsibilities:

• Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors.
• Provide oversight of statistical analysis plans, statistical outputs, and other documents as required.
• Provide statistical input into study protocols, Case Report Forms, and data management plans, DSMBs and write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
• Provide statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.
• Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
• When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
• Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.
• Contribute to the development of sourcing strategy for projects.
•  Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

Qualifications and Experience:

• Master's degree in Statistics, Biostatistics or related discipline
• 3-5 years' experience in statistical or biostatistical analysis supporting clinical trials' operations for the pharma/biotech industry
• Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and data submission to FDA required
• Working SAS & CDISC knowledge required
• Recent Oncology late-phase experience, with blood cancer and CAR T experience a plus.
• Late phase/submission experience, with strength in methodologies to adjust for cross-over (2-stage model, inverse probability of censoring waiting [IPSCW], rank-preserving structural failure time [RPSFT]) and methodologies to address non-proportional hazards (restricted mean survival time [RMST], piecewise cox proportional hazards model).