Overview
In this role you will lead statistical support for Phase I–IV trials and regulatory filings, guiding study design, analysis, and documentation. You will collaborate with cross-functional teams to optimize protocols, endpoints, and analysis strategies, ensuring high-quality statistical deliverables. You will oversee external vendors and contribute to regulatory interactions, SDTM/ADaM standards, and statistical sections of reports. This position offers an opportunity to shape statistical strategy across early to late-stage trials in a fast-paced, science-driven environment. You will work closely with medical writers and cross-functional teams to translate statistical decisions into regulatory
Pay / Benefits
- medical, dental and vision insurance
- retirement savings plan
- flexible paid vacation
- remote work options (as indicated by #LI-DM1-Remote)
- benefits information available on careers site
Responsibilities
- Participate in data science and cross-functional meetings to optimize study designs, endpoints, and analysis strategies
- Collaborate with study teams to meet timelines for study and recurring reports
- Support development and implementation of study protocols
- Review and contribute to data capture systems and their validation
- Develop statistical programs to simulate trial design operating characteristics and validate analyses
- Write statistical analysis plans and interpret analyses
- Support project lead statistician and regulatory meetings
- Respond to regulatory questions and monitor CRO guidelines
- Collaborate with statistical programming colleagues and review CRO deliverables
- Contribute as SMED for clinical reports and integrated summaries
- Learn regulatory requirements related to statistics and CDISC SDTM/ADaM standards
- Stay current with developments in statistics and regulatory guidance
Key requirements
- Knowledge of complex trial design and analysis including hypothesis testing, parametric/non-parametric models, and sample size calculations
- Experience with SAS and R; knowledge of other statistical languages a plus
- Understanding of ICH guidelines and drug development regulations for statistics
- Excellent written and verbal communication, attention to detail, and time management
- Ability to work in fast-paced, team-oriented environment
- PhD or MSc with relevant experience in pharmaceutical/biotech industry
- Proficient in statistical contributions to regulatory submissions
- interpersonal communication
- collaboration
- flexibility
- SAS
- R
- CDISC SDTM/ADaM
Principal Statistician, Biostatistics in London employer: Jazz Pharmaceuticals
Jazz Pharmaceuticals is an exceptional employer, offering a dynamic work culture that prioritises innovation and collaboration in the biopharma industry. With a strong commitment to employee growth, we provide numerous opportunities for professional development and a competitive benefits package, including flexible paid vacation and comprehensive health insurance. Located in vibrant cities like London and Cambridge, our employees enjoy a stimulating environment that fosters creativity and teamwork while making a meaningful impact on patients' lives worldwide.
