Trigent Software
2 weeks ago
Job Title : Senior/Principal Stat Programmer.
Employment Type : Full time.
Location : Bengaluru, India.
Job Responsibilities :
- 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, Figures for Integrated Summary of Safety (ISS) and Integrated.
- Summary of Efficacy (ISE).
- Create electronic submission package to FDA, i.e., define.xml or define.pdf following FDA guidelines with minimum supervision.
- Analyze information and develop innovative solutions to programming and data analysis challenges.
- Actively communicate with statisticians for statistical input and analysis interpretation.
- Follow and reinforce regulatory agency requirements during daily job.
- Serve as a programming team lead and contribute to department initiative.
- Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
- Review draft and final production deliverables for project to ensure quality and consistency.
Qualification : .
- Master's / Bachelor's degree in Statistics, Mathematics, Computer Science, Electrical Engineering,.
- Biotechnology or related scientific disciplines.
- Should have 8-13 years of experience in Statistical Programming in Clinical domain.
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