Senior Statistical Programmer

Description:

• Collaborates with the Clinical Data Programming & Biostatistics Coordinator to develop the Department activity plan and budget, managing activities within the allocated budget.
• Contributes to study design definition and develops the statistical section of CSPs or other regulatory documents.
• Develops SAPs (Statistical Analysis Plans).
• Conducts quality control of CDISC SDTM and ADaM Define.XMLs and Reviewer’s Guides from existing clinical study data.
• Performs quality control on generated outputs and the statistics section of final clinical documents (e.g., CSPs, CRFs, SAPs, and CSRs).
• Executes data analysis defined in SAPs, post-hoc analysis, and relevant exploratory analyses of clinical study data.

Requirements:

• Proficient in written and spoken English and Portuguese (spoken, written, and read).
• Strong statistical knowledge.
• Proficient in developing Statistical Analysis Plans.
• Bachelor's/master’s degree in bioinformatics, Computer Science, Statistics, or related areas.
• Over 5 years of programming skills (SAS, R, Python, etc.).
• Over 5 years of experience in generating CDISC SDTM and ADaM domain datasets, from clinical trials.