Principal Statistician, Biostatistics
Jazz Pharmaceuticals
6 months ago
Remote friendly (Palo Alto, CA)
United States
Clinical Research and Development
Principal Statistician, Biostatistics
Brief Description:
Lead statistician supporting the design and reporting of Phase I–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.
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 design operating characteristics; perform analysis, prepare data displays, and verify accuracy/validity of programmed analyses.
- Write statistical analysis plans; perform data analysis/validation and interpret results.
- 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.
- Perform other duties as assigned by the line manager.
- Serve as statistical subject matter expert with medical writers for clinical reports, integrated summaries, and other documents.
- Learn drug development regulatory requirements related to statistics, including marketing application contributions and CDISC SDTM/ADaM standards.
- Stay current via literature review, conferences, and professional development.
Required Knowledge, Skills, and Abilities:
- Clinical trial design and analysis, including complex statistical methods/models; statistical inference principles; hypothesis testing/estimates; parametric and non-parametric models; sample size calculation; design of experiments; Phase II–IV data analysis.
- Experience using SAS and R (other tools/languages a plus).
- Knowledge of applicable regulatory requirements/guidelines (e.g., ICH).
- Ability to work in a fast-paced, flexible, team-oriented environment.
- Excellent written and verbal interpersonal/communication skills.
- Strong attention to detail; positive/creative problem solver.
- Ability to work without close supervision with effective time management.
Education and Licenses:
- MS or MPH in statistics, mathematics, or related field (statistical focus) with > 2 years pharmaceutical/biotech industry experience; or
- PhD in statistics, mathematics, or related field (statistical focus) with < 2 years pharmaceutical/biotech industry experience.
Preferred:
- Bayesian and adaptive design knowledge.
- Proficient SAS & R; understanding of CDISC models/standards.
Compensation/Benefits (if US-based candidates only):
- Base pay range: $132,000.00 – $198,000.00.
- May be eligible for discretionary annual cash bonus/incentive and discretionary equity grants.
- Medical/dental/vision insurance, 401(k) retirement savings plan, and flexible paid vacation.
Application Instructions:
- If you are a current Jazz employee, apply via the Internal Career site.
Brief Description:
Lead statistician supporting the design and reporting of Phase I–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.
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 design operating characteristics; perform analysis, prepare data displays, and verify accuracy/validity of programmed analyses.
- Write statistical analysis plans; perform data analysis/validation and interpret results.
- 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.
- Perform other duties as assigned by the line manager.
- Serve as statistical subject matter expert with medical writers for clinical reports, integrated summaries, and other documents.
- Learn drug development regulatory requirements related to statistics, including marketing application contributions and CDISC SDTM/ADaM standards.
- Stay current via literature review, conferences, and professional development.
Required Knowledge, Skills, and Abilities:
- Clinical trial design and analysis, including complex statistical methods/models; statistical inference principles; hypothesis testing/estimates; parametric and non-parametric models; sample size calculation; design of experiments; Phase II–IV data analysis.
- Experience using SAS and R (other tools/languages a plus).
- Knowledge of applicable regulatory requirements/guidelines (e.g., ICH).
- Ability to work in a fast-paced, flexible, team-oriented environment.
- Excellent written and verbal interpersonal/communication skills.
- Strong attention to detail; positive/creative problem solver.
- Ability to work without close supervision with effective time management.
Education and Licenses:
- MS or MPH in statistics, mathematics, or related field (statistical focus) with > 2 years pharmaceutical/biotech industry experience; or
- PhD in statistics, mathematics, or related field (statistical focus) with < 2 years pharmaceutical/biotech industry experience.
Preferred:
- Bayesian and adaptive design knowledge.
- Proficient SAS & R; understanding of CDISC models/standards.
Compensation/Benefits (if US-based candidates only):
- Base pay range: $132,000.00 – $198,000.00.
- May be eligible for discretionary annual cash bonus/incentive and discretionary equity grants.
- Medical/dental/vision insurance, 401(k) retirement savings plan, and flexible paid vacation.
Application Instructions:
- If you are a current Jazz employee, apply via the Internal Career site.