Job Description

• ct as an integral member of the project team. Attending project team meetings, working with Biometrics vendor, biostatistician, data manager, medical lead, clinical trial manager and other functions to meet project deliverables and timelines.
• Manage all programming activities within a study, including timeline and resource planning.
• Lead or support the programming team and Biometrics vendors to produce SDTM/ADaM dataset, TFLs and supporting submission documents.
• Program statistical analyses using SASO supporting ad-hoc analysis, integrated analysis such as ISS and Client. Code SAS utility macros: implement test plans to support SAS macro development.
• Understands and follows FDA regulations which affect the reporting of clinical trial data.
• Participates in cross functional initiatives representing Statistical Programming.
• Provide review and input to study documents and processes (such as Statistical Analysis Plans, eCRFs, SOPs, etc.).
• Understand and follow FDA regulations which affect the reporting of clinical trial data.
• Develop and/or contribute to data collection, analysis and reporting standards content and processes.
• Mentor junior level staff in programming practices.

• Bachelor's or higher degree in Statistics, Computer Science, Mathematics, Engineering or related discipline.
• t least five (with Bachelor's degree) or four (with master's degree) years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry.
• Excellent technical skills; familiarity with coding dictionaries.
• Experience and in-depth knowledge of CDISC standards, including SDTM, ADaM, and controlled terminologies.
• bility to communicate technical concepts clearly and concisely to non-technical colleagues.
• Strong organizational skills, attention to detail, and self-motivation.
• Vendor management experience.
• Experience in creating all components of a submission package.
• Oncology Therapeutic area experience.
• RTOR experience.

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