- - Serve as the Lead Programmer and Manager of the statistical programming efforts.
- - 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.
- - Independently develop and validate programs that generate protocol-specific efficacy tables, listings, figures/graphs using Alexion specifications.
- - Ensure that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.
- - Directly support the Clinical and Statistical Programming Director in all aspects of the management and development of the Statistical Programming team.
- - Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary.
- - Create and/or review programming plans, and ensure appropriate resource allocation and prioritization.
- - Act as the primary department contact to ensure that department standards are implemented in all studies.
- - Manage adherence to all company policies, SOPs, and other controlled documents; ensure all programming activities adhere to departmental standards.
- - Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support.
Essential Skills/Experience
- - 7+ years statistical programming experience in the CRO or Pharmaceutical Industry.
- - 4+ years project management experience in the CRO or Pharmaceutical Industry.
- - Experience with CDISC SDTM and ADaM models and transforming raw data into those standards.
- - Strong people management skills and supervisory skills gained from direct line management or supervisory experience. Proven abilities to lead and manage cross-functional projects, and people, from concept to completion.
- - Strong verbal and written communication skills - ability to clearly and effectively present information.
- - An excellent understanding of the roles and responsibilities of all related disciplines, in particular Biostatistics, Clinical Data Management, and Pharmacovigilance.
- - Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment with a demonstrated mastery of SAS/STAT procedures.
- - Extensive experience and proven skills in the use of SAS within a Statistical Programming environment to develop and validate analysis datasets, tables, listings, and figures/graphs.
- - Knowledge of clinical database design, specifically electronic data capture using Inform, Medidata, and Oracle.
- - Advanced experience with:
- - Constructing technical programming specifications.
- - Relational Databases.
- - Good Clinical Practices.
- - Good Programming Practices.
- - 21CFR Part 11 Standards.
- - Integrated Summary Safety/Efficacy Analyses.
- - Creating all files necessary to support an electronic submission in the eCTD format.
Desirable Skills/Experience
- - BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.
- - Competencies:
- - Accountability
- - Collaboration
- - Decision Quality
- - Drive for Results
- - Perseverance
- - Problem Solving
- - Informing
- - Peer Relationships
- - Time Management
- - Building Effective Teams
- - Managing Through Systems
