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Responsibilities:

• Efficient programming techniques.
• Creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
• Contribution to and review of statistical analysis plans and analysis datasets specifications.
• Prepare the electronic submission of clinical trial data to regulatory authorities.
• Anticipate statistical programming resource needs and work with management to ensure adequate long-term resource allocation within a project.
• Provide effective solutions for complex statistical programming tasks.
• Provide input or lead data standardization efforts (e.g., CRF and database design, edit checks, standard statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions).
• Create and manage the project and study electronic subdirectories ensuring consistency in structure.
• Contribute to the design, creation, and validation of global programming macros that streamline programming activities and increase efficiency.
• Participate in the development of new processes or revision of existing processes.
• Keep current with new statistical programming techniques and technological advancements.
• As necessary, provide work direction, guidance, mentoring, influence, and support to junior staff. Train junior staff in more complex statistical programming techniques.

Requirement:

• Bachelor's Degree in Statistics/Biostatistics, Computer Science, or Mathematics.
• 5+ years of experience as a statistical programmer in the pharmaceutical industry
• Working knowledge of clinical research, Good Clinical Practices, and regulatory requirements/guidelines.
• Technically strong with regard to statistical programming processes and activities.
• Highly proficient in SAS.
• Experience as a lead statistical programmer on several concurrent projects.
• Understanding of CDISC STDM/ADaM guidelines.
• Excellent English verbal and written communication skills; good organizational and interpersonal skills.