Expert knowledge of clinical trial data analysis processes and SAS programming
Excellent knowlegde of implementing CDISC Standards - SDTM, ADaM, Creation of SDRG, ADRG, Define.xml
Prior strong experience in one or two therapeutic areas
Prior experience of working on analysis of both safety and Efficacy data
Prior experience of leading the studies and managing a team of 5-8 programmers
Prior of experience of creating or maintaining system-level macros
Prior experience of working with study deliverables like DMC, QRS, ASCO, BDR, CSR, Interim CSR
Project management skills, including time management, planning, work allocation and project delivery
Ability to coordinate with all functional areas that make up a clinical project team and to interface with different cultures, both internally and externally.
Responsibilities:
Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents.
Develop specifications (Defines) and create SAS programs for the mapping of raw datasets to CDISC SDTM and ADaM standards.
Develop SAS programs to produce Analysis datasets, statistical table, listing figures in accordance with the Statistical Analysis Plan (SAP).
Support, and assess the feasibility of, ad hoc/exploratory analyses.
