Trigent Software
1 month 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, 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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bangalore, India Trigent Software Inc Full timeTitle: Statistical ProgrammerLocation: RemoteDuration: Full-timeResponsibilities:• Develop and maintain programs using R to generate Tables, Listings, and Figures (TLFs) as part of clinical trial reporting.• Implement CDISC standards (SDTM, ADaM) for clinical data submission and reporting.• Manage clinical datasets and ensure data integrity, quality,...
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bangalore, India Trigent Software Inc Full timeTitle: Principal Clinical Data Science Programmer Location: Bangalore/ Chennai/ Trivandrum Duration: Full-time Description: • More than 6 years’ experience as a Business Analyst, working within Data warehouse platforms in a regulated industry OR mutually agreed based upon desired competencies • Clinical Data Knowledge or SDTM knowledge (required) •...
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bangalore, India Trigent Software - Professional Services Full timeJob 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...
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bangalore, India Trigent Software - Professional Services Full timeJob 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...
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Bangalore, India Trigent Software - Professional Services Full timeJob Title: End-to-End Recruiter (Full-Time Hiring) – FTE / CH2 / RPO Experience We are seeking a proactive and experienced End-to-End Recruiter to join our growing team. The ideal candidate will have in-depth experience with full-time (FTE) hiring and bring a proven track record in CH2 and Recruitment Process Outsourcing (RPO) environments. The...
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