Senior Statistical Programmer II

• 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.