Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.
The Associate Director, Statistical Programming will function as a programming lead on Jazz Pharmaceuticals clinical development projects. This position will work collaboratively with biostatisticians, clinicians, data managers in the planning, conduct, and analysis of clinical studies in all phases.
- Lead Statistical Programmer on multiple complex projects or products in the Statistical Programming function, including NDA/BLA and other submissions to regulatory agencies
- Lead, manage, coach, develop, and support Statistical Programmers within the Biostatistics Department
- Author or provide input to key study-related documents produced by other functions (e.g. Statistical Programming Plan, SAP, CRFs, Data Management Plan, etc.)
- Ensure the quality of Statistical Programming deliverables, including oversight of CRO biostatistics deliverables
- Participate and/or lead in the development and implementation of SAS programming standards, SOPs and work instructions, including program validation and documentation
- Ensure that the filing of study documentation is maintained to the standard required according to processes and is acceptable for audit
- Participate in vendor qualification/selection and monitor vendor performance
- Perform/assess time and resource estimates for project planning, managing timelines for studies/projects
Required Knowledge, Skills, and Abilities
- Thorough knowledge of statistics and the drug development process
- Understanding of SAS programming concepts and techniques in the pharmaceutical industry and ability to correct limitations in strategy proactively
- Ability to manage multiple complex projects and assess resource needs
- Extensive knowledge and implementation experience with CDISC standards
- Excellent verbal and written communication within the Biostatistics group and across other functional areas.
- Excellent SAS Programming skills, and the ability and willingness to work hands on (study level programming support) if necessary
Required/Preferred Education and Licenses
- Bachelor or Master's Degree in Statistics, Mathematics, or related fields; A Master's degree is preferred
- 10+ years of statistical programming experience in the Pharmaceutical/Biotech Industry or CRO with 3+ years of supervisory experience
- 5+ years of experience within Statistical Programming in Oncology Therapeutic area.
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.