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.

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.

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