Sr Principal Statistician
Jazz Pharmaceuticals
August 19, 2026
Remote friendly (Philadelphia, PA)
United States
Clinical Research and Development
Brief Description
The Senior Principal Statistician, Biostatistics will lead statistics for individual and integrated clinical studies and integrated summaries. Designs and reports Phase I–IV clinical studies and regulatory filings under supervision of a more senior statistician. Responsible for statistical aspects of study design, analysis/validation, and study documentation; develops and executes statistical strategy, design, and analyses for clinical trials; partners with cross-functional teams and manages external biostatistics/programming vendors.
Responsibilities
- Optimize clinical study designs, endpoints, and analysis strategies in protocols.
- Support development/implementation of study protocols.
- Review/input to data capture systems and participate in validation.
- Develop statistical programs (simulation, analyses, data displays); verify accuracy/validity.
- Write/review statistical analysis plans; oversee/interpret analyses and validations.
- Prepare for and attend regulatory agency meetings.
- Review timelines and CRO analysis plans; ensure CRO deliverable timeliness and quality.
- Serve as statistical SME for clinical reports, integrated summaries, and other documents.
- Respond to statistical questions from regulatory agencies.
Required/Preferred Qualifications & Skills
- MS/MPH in statistics/mathematics (statistical focus) + >4 years pharma/biotech experience OR PhD + >2 years.
- Knowledge of clinical trial design/analysis and complex statistical methods/models (inference, hypothesis testing, estimates, parametric/non-parametric methods, sample size, design of experiments); Phase II–IV data analysis.
- Proficient in SAS and R (other languages a plus).
- Knowledge of regulatory requirements/guidelines (e.g., ICH), CDISC standards, and statistical contributions to marketing applications.
- Excellent communication, interpersonal skills, attention to detail, ability to work without close supervision, and strong time management.
- Preferred: oncology/hematology knowledge; Bayesian and adaptive design experience; leadership abilities and advanced writing.
Application Instruction
- If a current Jazz employee, apply via the Internal Career site.
The Senior Principal Statistician, Biostatistics will lead statistics for individual and integrated clinical studies and integrated summaries. Designs and reports Phase I–IV clinical studies and regulatory filings under supervision of a more senior statistician. Responsible for statistical aspects of study design, analysis/validation, and study documentation; develops and executes statistical strategy, design, and analyses for clinical trials; partners with cross-functional teams and manages external biostatistics/programming vendors.
Responsibilities
- Optimize clinical study designs, endpoints, and analysis strategies in protocols.
- Support development/implementation of study protocols.
- Review/input to data capture systems and participate in validation.
- Develop statistical programs (simulation, analyses, data displays); verify accuracy/validity.
- Write/review statistical analysis plans; oversee/interpret analyses and validations.
- Prepare for and attend regulatory agency meetings.
- Review timelines and CRO analysis plans; ensure CRO deliverable timeliness and quality.
- Serve as statistical SME for clinical reports, integrated summaries, and other documents.
- Respond to statistical questions from regulatory agencies.
Required/Preferred Qualifications & Skills
- MS/MPH in statistics/mathematics (statistical focus) + >4 years pharma/biotech experience OR PhD + >2 years.
- Knowledge of clinical trial design/analysis and complex statistical methods/models (inference, hypothesis testing, estimates, parametric/non-parametric methods, sample size, design of experiments); Phase II–IV data analysis.
- Proficient in SAS and R (other languages a plus).
- Knowledge of regulatory requirements/guidelines (e.g., ICH), CDISC standards, and statistical contributions to marketing applications.
- Excellent communication, interpersonal skills, attention to detail, ability to work without close supervision, and strong time management.
- Preferred: oncology/hematology knowledge; Bayesian and adaptive design experience; leadership abilities and advanced writing.
Application Instruction
- If a current Jazz employee, apply via the Internal Career site.