POSITION OBJECTIVE: Provide Statistical Programming Support for Clinical Data Analysis and Submission.
Essential Job Functions/Responsibilities
This role is expected to contribute to the quality of data analysis and reporting deliverables for phase I to III clinical trials.
- Provide programming support for the clinical study team by generating and maintaining patient profiles, tables, listings, figures and other types of outputs
- Create annotated CRFs, mapping specifications and datasets per SDTM standards
- Review analysis data specifications and create ADaM analysis datasets per Statistical Analysis Plan and ADaM data standards
- Review Table/Figure/Listing shells for Clinical Study Report and produce tables, figures and listings accordingly
- Perform program validation for external vendors and/or internal staff, as appropriate
- Ensure that each statistical reporting deliverable has necessary and sufficient documentation as required by the company’s SOPs
Required Education & Qualifications
- Bachelor’s degree in Biostatistics, Statistics, or Relevant Fields required; Master’s degree preferred
- 1 to 3 years of experience in statistical data reporting for clinical studies
- Strong SAS programming skills
- Knowledge in creation of CDISC SDTM and ADaM data structures
- Have strong verbal and written communication skills in English
- Prior experience in therapeutic area of Oncology is preferred