Chennai, Tamil Nadu 8-13 Yrs ₹04 - ₹10 Yearly
Job description
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.
Candidate Profile:
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.