The Manager, Biostatistics will be acting as a project-level and study-level statistician. This role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing, data management, clinical operations, biostatistics, and statistical programming and will oversee the work of biostatistics external vendors.
- Provide timely and scientifically sound statistical expertise to clinical development projects.
- Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies.
- Collaborate with members of project teams to establish project timelines and to develop and implement protocols
- Work closely with data management, clinical operations, statistical programming, and other biostatisticians to develop and possibly validate study-specific data capture systems
- Develop statistical analysis plans, coordinate and perform data analysis and validation as necessary, and provide data interpretation.
- Manage CROs regarding statistical issues and activities to ensure timely delivery of analysis results. Provide guidelines and standards to CROs to ensure quality of deliverables. Participate in CRO selection process.
- Attend regulatory meetings to support and defend clinical programs as necessary.
- Stay current with new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc.
Preferred Knowledge, Skills, and Abilities
- Advanced knowledge of clinical trial design and analysis
- Proficient in US drug development regulatory requirements as they relate to statistics
- Experience in contributing to NDAs or BLAs
- Proficient in using SAS; knowledge of other statistical applications and programming languages a plus
- Experience with CDISC SDTM and ADaM models and standards
- Excellent oral and written communications skills
- MS/MPH or PhD in statistics, mathematics, or other applicable field, with 8+ years (MS) or 4+ years (PhD) of pharmaceutical/biotech industry, clinical research or other applicable experience.
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
- Occasional public contact requiring appropriate business apparel.
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.