Principal Statistician, Biostatistics
Jazz Pharmaceuticals
6 months ago
Remote friendly (Philadelphia, PA)
United States
Clinical Research and Development
Brief Description
- The Principal Statistician, Biostatistics will be a lead statistician supporting the design and reporting of Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. Responsible for statistical aspects of study design, study analysis/validation, and study documentation.
- Develop and execute statistical strategy, design, and analyses for clinical trials; oversee work by statistics and programming external vendors.
- Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
Essential Functions
- Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
- Collaborate with study teams to meet study and recurring report timelines.
- Support development and implementation of study protocols.
- Review and provide input to study-specific data capture systems; participate in their validation.
- Develop statistical programs to simulate trial operating characteristics, perform analysis, prepare data displays, and verify accuracy/validity of programmed analyses.
- Write statistical analysis plans; perform data analysis/validation and interpret analyses.
- Support the project lead statistician.
- Prepare for and attend regulatory agency meetings; respond to statistical questions.
- Work closely with statistical programming colleagues.
- Monitor CRO guidelines/standards; review and validate CRO deliverables.
- Collaborate with medical writers on clinical reports, integrated summaries, and other documents.
- Learn and apply drug development regulatory requirements related to statistics (including marketing applications and CDISC SDTM/ADaM).
- Stay current via literature review, conference attendance, and professional development.
- Other work as assigned by line manager.
Required Knowledge, Skills, and Abilities
- Clinical trial design and analysis, including complex statistical methods/models; statistical inference, hypothesis testing, estimates; parametric/non-parametric methods; sample size calculations; experimental design; Phase II–IV data analysis.
- SAS and R experience (other languages/applications a plus).
- Knowledge of applicable regulatory requirements/guidelines (e.g., ICH).
- Ability to work in a fast-paced, flexible, team-oriented environment.
- Strong written/verbal interpersonal and communication skills.
- Strong attention to detail; flexible, positive, creative thinker; effective time management; able to work without close supervision.
Required/Preferred Education and Licenses
- MS or MPH in statistics, mathematics, or related field with statistical focus and > 2 years pharmaceutical/biotech industry experience.
- PhD in statistics, mathematics, or related field with statistical focus and < 2 years pharmaceutical/biotech industry experience.
- Knowledge of drug development regulations pertinent to statistical analysis.
- Bayesian and adaptive design knowledge preferred.
- Proficient SAS & R; understanding of CDISC models/standards.
- Excellent writing/communication skills; demonstrated leadership and interpersonal skills.
Benefits (if US-based)
- Eligible for discretionary annual cash bonus/incentive (depending on role) and discretionary equity grants.
- Medical, dental, and vision insurance; 401(k); flexible paid vacation.
Application Instructions
- If a current Jazz employee: apply via the Internal Career site.
- The Principal Statistician, Biostatistics will be a lead statistician supporting the design and reporting of Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. Responsible for statistical aspects of study design, study analysis/validation, and study documentation.
- Develop and execute statistical strategy, design, and analyses for clinical trials; oversee work by statistics and programming external vendors.
- Collaborate with clinical development, pharmacology, pharmacovigilance, clinical drug supply, project management, regulatory affairs, medical writing, clinical data management, and clinical operations.
Essential Functions
- Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
- Collaborate with study teams to meet study and recurring report timelines.
- Support development and implementation of study protocols.
- Review and provide input to study-specific data capture systems; participate in their validation.
- Develop statistical programs to simulate trial operating characteristics, perform analysis, prepare data displays, and verify accuracy/validity of programmed analyses.
- Write statistical analysis plans; perform data analysis/validation and interpret analyses.
- Support the project lead statistician.
- Prepare for and attend regulatory agency meetings; respond to statistical questions.
- Work closely with statistical programming colleagues.
- Monitor CRO guidelines/standards; review and validate CRO deliverables.
- Collaborate with medical writers on clinical reports, integrated summaries, and other documents.
- Learn and apply drug development regulatory requirements related to statistics (including marketing applications and CDISC SDTM/ADaM).
- Stay current via literature review, conference attendance, and professional development.
- Other work as assigned by line manager.
Required Knowledge, Skills, and Abilities
- Clinical trial design and analysis, including complex statistical methods/models; statistical inference, hypothesis testing, estimates; parametric/non-parametric methods; sample size calculations; experimental design; Phase II–IV data analysis.
- SAS and R experience (other languages/applications a plus).
- Knowledge of applicable regulatory requirements/guidelines (e.g., ICH).
- Ability to work in a fast-paced, flexible, team-oriented environment.
- Strong written/verbal interpersonal and communication skills.
- Strong attention to detail; flexible, positive, creative thinker; effective time management; able to work without close supervision.
Required/Preferred Education and Licenses
- MS or MPH in statistics, mathematics, or related field with statistical focus and > 2 years pharmaceutical/biotech industry experience.
- PhD in statistics, mathematics, or related field with statistical focus and < 2 years pharmaceutical/biotech industry experience.
- Knowledge of drug development regulations pertinent to statistical analysis.
- Bayesian and adaptive design knowledge preferred.
- Proficient SAS & R; understanding of CDISC models/standards.
- Excellent writing/communication skills; demonstrated leadership and interpersonal skills.
Benefits (if US-based)
- Eligible for discretionary annual cash bonus/incentive (depending on role) and discretionary equity grants.
- Medical, dental, and vision insurance; 401(k); flexible paid vacation.
Application Instructions
- If a current Jazz employee: apply via the Internal Career site.