- Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
- Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
- Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP.
- Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications.
- Supervise/manage external vendors and contract programmers.
- Oversee progress of programming activities.
- Review, maintain, and approve protocol-specific documents as necessary.
- Provide guidance and mentoring to peer and junior-level Programmers.
- Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.
- Contribute ideas and thoughts towards the optimization of standard operating procedures.
- Lead team meetings when appropriate.
- Any other activities as required.
Essential Skills/Experience:
- Bachelor s Degree (Minimum) or Master s Degree (Preferred) in Biostatistics, Statistics or another related discipline
- Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
- Proven ability to:
- Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs.
- Independently and collaboratively resolve problems
- Clearly communicate processes and standards with management and team members
- Expertise in using SAS/Base, SAS/Macro, SAS/STAT.
- Knowledge of SAS/Graph, and SAS/SQL
- Knowledge of:
- SDTM and ADaM
- Relational Databases.
- Good Clinical Practices.
- Good Programming Practices.
- 21CFR Part 11 Standards.
- Integrated Summary Safety/Efficacy Analyses.
- Safety data and Coding Dictionaries (MedDRA and WHODD).
- ICH eCTD format.
