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Sr. Statistical Programmer

As per the market standards



Skill Set:

  • 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.