Vacancy expired!
Kelly Scientific is seeking a Statistical Programmer for a fully remote, direct hire (perm) opportunity who is experienced in statistical programming activities related to the analyses of clinical trial data ensuring timelines and company strategic objectives are met. They contribute to process improvements and initiatives within the Biometrics department.
This is an exciting opportunity to join a leader in the industry in developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells.ESSENTIAL FUNCTIONS- Lead aspects of the statistical programming activities, including
- 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
- 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
- Bachelor's Degree in Statistics/Biostatistics, Computer Science, or Mathematics
- 2+ 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
Vacancy expired!