Trigent Software

1 week ago

bangalore, India Trigent Software - Professional Services Full time

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, e.g., 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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