Senior Principal Statistician
Jazz Pharmaceuticals
August 19, 2026
Remote friendly (Palo Alto, CA)
United States
Clinical Research and Development
Senior Principal Statistician, Biostatistics
Responsibilities:
- Lead statistical design, analysis, validation, and documentation for Phase I–IV clinical studies and integrated summaries/regulatory filings under supervision.
- Develop and execute statistical strategy, design, and analyses for clinical trials; provide timely, scientifically sound statistical expertise to clinical development projects.
- Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
- Manage external vendor work for biostatistics, statistics, and programming deliverables.
- Optimize protocols (endpoints and analysis strategies), support protocol development, and review data capture systems.
- Develop statistical programs (simulation, analysis, data displays), and verify analysis accuracy/validity.
- Write/review statistical analysis plans; perform/oversee data analysis and validation; interpret results.
- Prepare for and attend regulatory agency meetings; respond to statistical questions.
- Review CRO timelines, analysis plans, and deliverables; act as statistical subject matter expert for clinical reports/integrated summaries.
Required skills/knowledge:
- Clinical trial design and analysis expertise (complex methods/models; hypothesis testing; estimates; parametric/non-parametric methods; sample size calculations; design of experiments; Phase II–IV data analysis).
- SAS and R; knowledge of other tools/languages a plus.
- Knowledge of regulatory/statistical guidelines (e.g., ICH), marketing application statistical contributions, and CDISC standards.
- Strong communication (written/verbal), attention to detail, ability to work in fast-paced teams, and time management.
Required education/experience:
- MS/MPH in statistics/mathematics/related field (statistical focus) + >4 years in pharma/biotech OR PhD (statistical focus) + >2 years.
Preferred:
- Oncology/hematology therapeutic area knowledge.
- Bayesian and adaptive design experience.
Benefits (if eligible): medical, dental, vision; 401k; flexible paid vacation.
Application instruction: If a current Jazz employee, apply via the Internal Career site.
Responsibilities:
- Lead statistical design, analysis, validation, and documentation for Phase I–IV clinical studies and integrated summaries/regulatory filings under supervision.
- Develop and execute statistical strategy, design, and analyses for clinical trials; provide timely, scientifically sound statistical expertise to clinical development projects.
- Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
- Manage external vendor work for biostatistics, statistics, and programming deliverables.
- Optimize protocols (endpoints and analysis strategies), support protocol development, and review data capture systems.
- Develop statistical programs (simulation, analysis, data displays), and verify analysis accuracy/validity.
- Write/review statistical analysis plans; perform/oversee data analysis and validation; interpret results.
- Prepare for and attend regulatory agency meetings; respond to statistical questions.
- Review CRO timelines, analysis plans, and deliverables; act as statistical subject matter expert for clinical reports/integrated summaries.
Required skills/knowledge:
- Clinical trial design and analysis expertise (complex methods/models; hypothesis testing; estimates; parametric/non-parametric methods; sample size calculations; design of experiments; Phase II–IV data analysis).
- SAS and R; knowledge of other tools/languages a plus.
- Knowledge of regulatory/statistical guidelines (e.g., ICH), marketing application statistical contributions, and CDISC standards.
- Strong communication (written/verbal), attention to detail, ability to work in fast-paced teams, and time management.
Required education/experience:
- MS/MPH in statistics/mathematics/related field (statistical focus) + >4 years in pharma/biotech OR PhD (statistical focus) + >2 years.
Preferred:
- Oncology/hematology therapeutic area knowledge.
- Bayesian and adaptive design experience.
Benefits (if eligible): medical, dental, vision; 401k; flexible paid vacation.
Application instruction: If a current Jazz employee, apply via the Internal Career site.