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Active7h ago

Senior Statistical Programmer / Analyst II

ClinChoice·📍 Pasig City, Philippines

Employment

FULL TIME

Work mode

On-site

Experience

4+ years

Salary

Not disclosed

Salary not disclosed

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Role overview

Job description

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. Proficient in analyze information and develop innovative solutions to programming and data analysis challenges; Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation Follow and reinforce regulatory agenc

What they are looking for

Skills & requirements

pythonjavasqlmachine learningaic++gosemclinicaltraining

Department · Statistical Programming

C

Hiring company

ClinChoice

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