Senior Principal Statistician, Biostatistics (Remote)
Jazz Pharmaceuticals
- Carlsbad, CA Harrisburg, PA
- Permanent
- Full-time
- 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 any recurring 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 as necessary to simulate clinical trial design operating characteristics, perform analysis, prepare data displays, verify data accuracy and validity of analyses performed by statistical programming.
- Write statistical analysis plans, review statistical analysis plans written by other statisticians, perform and oversee data analysis and validation, and interpret analyses.
- Prepare for and attend meetings with regulatory agencies.
- Work with biostatistics compound/therapeutic area lead, peer management, and employees to develop, implement, and maintain department standards and practices.
- Review timelines and analysis plans for CRO work to ensure timeliness and quality deliveries.
- Review and validate CRO deliverables.
- Act as the statistical subject matter expert with medical writers and other colleagues in the production of clinical reports, integrated summaries, and other documents.
- Respond to statistical questions from regulatory agencies.
- Knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis.
- Experience in using SAS and R; knowledge of other statistical applications and programming languages a plus.
- Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC standards.
- Able to work in a fast-paced, flexible, team-oriented environment.
- Possess excellent interpersonal and communication skills (written and verbal).
- Strong attention to detail with a view to bring studies to a quality conclusion.
- Flexible, positive, creative thinker, good communicator.
- Work without close supervision. Well-developed time management skills are important.
- MS or MPH in statistics, mathematics, or a related discipline with a statistical focus and
- Knowledge of the oncology or hematology therapeutic area is preferred
- Bayesian and adaptive design experience is preferred.
- Proficient SAS & R programming skills, solid understanding of CDISC models and standards.
- Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills.