As a senior statistical programmer you will analyse information and develop innovative solutions to programming and data analysis challenges.
- Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines
- Develop SDTM specifications and generate SDTM datasets using SAS
- Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
- Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts
- Develop ADaM data, Tables, Listings and Figures for Integrated Summary of Safety and Integrated Summary of Efficacy
- Create electronic submission package to regulator, e.g., define.xml or define.pdf following guidelines with minimum supervision
- Actively communicate with statisticians for statistical input and analysis interpretation
- Follow and reinforce regulatory agency requirements during daily job
- Provide support for team members and help solve issues from cross-functional teams.
- Review draft and final production deliverables for project to ensure quality and consistency
Your skills and experience:
- Bachelor's/Master's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines or extensive relevant experience
- Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and/or SQL.
- Database programming experience is a plus.
- Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members
If this is you and you have at least 3 years of clinical programming experience - get in touch today for your next career step.