Senior/principal statistical programmer

1 month 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 ADa M,specifications and generate ADa M datasets using SAS based on Statistical Analysis Plan. • Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts. • Develop ADa M 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.

  • Senior/Principal Statistical Programmer

    1 month 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...

  • Senior/Principal Statistical Programmer

    1 month ago

    bangalore, India Trigent Software - Professional Services Full time

    Job Title: Senior/Principal Stat ProgrammerEmployment Type: Full timeLocation: Bengaluru, IndiaJob 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...

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  • Senior/ Principal Statistical Programmer

    1 month ago

    bangalore, India Veramed Full time

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    1 month ago

    bangalore, India Excelya Full time

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    bangalore, India Excelya Full time

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  • Principal statistical programmer

    1 month ago

    Bangalore, India Excelya Full time

    Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas. We take a one-team approach to work: our shared success is the result of collaboration at every stage of...

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    1 month ago

    Bangalore, India Excelya Full time

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  • Principal Statistical Programmer

    1 month ago

    bangalore, India Excelya Full time

    Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas. We take a one-team approach to work: our shared success is the result of collaboration at every stage of a...

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    2 months ago

    bangalore, India IQVIA Full time

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    2 months ago

    bangalore, India IQVIA Full time

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