Collaborates with the study statistician to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content
Leads the production and validation efforts for the designed output, this may include oversight of work by CROs
Collaborates with peers and statisticians to ensure the quality and accuracy –thus submission readiness –of clinical data as required by authorities
Supports the review of related deliverables when provided by CROs
Leads requested efforts for pooled and exploratory analyses working closely with clinical programming team and their collection of legacy data
Works closely with clinical study teams to ensure that project timelines are met with high quality deliverables
Requirements
BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
At least 5 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software
Understanding of clinical programming and/or statistical programming processes and standards
Experiences with statistical programming using the SAS software including development and use of SAS Macros
Knowledge in CDISC standards (CDASH, SDTM, ADaM)
Ability to work effectively in a team setting, and to meet set goals by managing own timelines