Trigent Software - Senior/Principal Statistical Programmer (8-13 yrs)

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.