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About the Role
The Senior Principal Statistician, Biostatistics will serve as a lead statistician for individual studies, related studies, and integrated summaries. This role is responsible for all statistical aspects of study design, analysis, validation, and documentation, providing statistical expertise to clinical development projects and developing statistical strategy for clinical trials. The position involves collaboration with various cross-functional teams and managing external vendor work.
Responsibilities
- Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies in protocols.
- Collaborate with cross-functional team members to meet study report timelines.
- Support the development and implementation of study protocols.
- Review and provide input to data capture systems and participate in their validation.
- Develop statistical programs to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, and verify data accuracy and validity of analyses.
- Write and review statistical analysis plans, perform and oversee data analysis and validation, and interpret analyses.
- Prepare for and attend meetings with regulatory agencies.
- Develop, implement, and maintain department standards and practices with leadership.
- Review timelines and analysis plans for CRO work to ensure timeliness and quality.
- Review and validate CRO deliverables.
- Act as the statistical subject matter expert for clinical reports, integrated summaries, and other documents.
- Respond to statistical questions from regulatory agencies.
Requirements
- Knowledge of clinical trial design and analysis, including complex statistical methods and models.
- Understanding of statistical principles and methodology, including statistical inference, hypothesis testing, estimates, parametric and non-parametric models, sample size calculations, and principles of design of experiments.
- Experience with Phase II-IV clinical trial data analysis.
- Experience using SAS and R.
- Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines.
- Understanding of statistical contributions to marketing applications and CDISC standards.
- Ability to work in a fast-paced, flexible, team-oriented environment.
- Excellent interpersonal and communication skills (written and verbal).
- Strong attention to detail.
- Flexible, positive, creative thinker, good communicator.
- Ability to work without close supervision.
- Well-developed time management skills.
Skills
- SAS
- R
- Statistical analysis
- Clinical trial design
- Regulatory guidelines
- CDISC standards
- Communication skills
- Interpersonal skills
- Time management
Location
- Remote
Work Type
- Full-time
Experience Level
- Senior Principal
Education Level
- MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and > 4 years of experience in pharmaceutical or biotechnology industry.
- PhD in statistics, mathematics, or a related discipline with a statistical focus and > 2 years of experience in the pharmaceutical or biotechnology industry.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Retirement savings plan
- Flexible paid vacation
About the Company
- Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for patients with serious diseases, often with limited or no therapeutic options.
- The company has a diverse portfolio of marketed medicines, including therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
- Jazz Pharmaceuticals' patient-focused and science-driven approach powers pioneering research and development advancements across its pipeline in oncology and neuroscience.
- Headquartered in Dublin, Ireland, Jazz Pharmaceuticals has research and development laboratories, manufacturing facilities, and employees in multiple countries serving patients worldwide.
- More information can be found at www.jazzpharmaceuticals.com.
Equal Opportunity
- Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.