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.