- Support development of technical programming specifications for SDTM, ADS or ADaM standards.
- Independently develop and/or validate programs that generate SDTM, and analysis datasets based on Alexion or ADaM specifications.
- Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP.
- Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications.
- Manage external vendors and contract programmers.
- Provide project progress updates of programming activities.
- Review, maintain, and approve protocol specific documents as necessary.
- Provide guidance and mentoring to peer, junior-level Programmers and contract staff.
- Support project leadership ensuring 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:
- Minimum of 6 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
- High competence in using SAS/Base, SAS/Macro, SAS/STAT.
- Knowledge of SAS/Graph, and SAS/SQL
- Knowledge and implementation of:
- SDTM and ADaM principals
- Relational Databases.
- Good Clinical Practice principals.
- Good Programming Practice principals.
- 21CFR Part 11 Standards principals.
- Integrated Summary Safety/Efficacy Analyses.
- Safety data and Coding Dictionaries (MedDRA and WHODD).
- ICH eCTD format.
