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.
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