[Hiring] Senior Principal Statistician @Jazz Pharmaceuticals

Role Description

The Senior Principal Statistician, Biostatistics will be a lead statistician on individual studies, across related studies, and for integrated summaries. This role is responsible for all statistical aspects of study design, study analysis and validation, and study documentation.

• Design and report Phase I to IV clinical studies and regulatory filings under supervision.
• Provide timely and scientifically sound statistical expertise to clinical development projects.
• Develop and execute statistical strategy, design, and analyses for clinical trials.
• Collaborate with various departments including clinical development, pharmacology, and regulatory affairs.
• Manage work done by statistics and programming external vendors.

Essential Functions

• 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 and verify data accuracy.
• Write and review statistical analysis plans, perform and oversee data analysis and validation.
• Prepare for and attend meetings with regulatory agencies.
• Work with biostatistics compound/therapeutic area lead to maintain department standards and practices.
• Review timelines and analysis plans for CRO work to ensure quality deliveries.
• Act as the statistical subject matter expert with medical writers and colleagues in the production of clinical reports.
• Respond to statistical questions from regulatory agencies.

Qualifications

• Knowledge of clinical trial design and analysis, including complex statistical methods and models.
• Experience in using SAS and R; knowledge of other statistical applications is a plus.
• Knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines.
• Able to work in a fast-paced, flexible, team-oriented environment.
• 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.

Requirements

• MS or MPH in statistics, mathematics, or a related discipline with > 4 years of experience in pharmaceutical or biotechnology industry.
• PhD in statistics, mathematics, or a related discipline with > 2 years of experience in the pharmaceutical or biotechnology industry.
• Knowledge of drug development regulations pertinent to statistical analysis.
• 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.

Benefits

• Medical, dental, and vision insurance.
• 401k retirement savings plan.
• Flexible paid vacation.
• Discretionary annual cash bonus or incentive compensation.
• Discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan.