Address
Form of workResponsibilities:
- Generate and validate tables, listings, and figures (TLF) based on statistical analysis plan (SAP)
- Work with statistician to provide statistical analysis support for publication effort
- Use major statistical programming language to perform data analysis for various needs
- Provide statistical analysis support for post approval studies
- Write specifications and statistical programs to generate analysis datasets and outputs data analysis tasks with minimal supervision
- Work with statisticians to develop statistical toolbox for advanced data modelling, tabulation, and visualization
- At 3+ years' experience in medical device, pharmaceutical, biotech and/or CRO industries
- Strong SAS programming skill in producing various types of outputs such as TLFs and datasets
- Extensive statistical programming experience in producing deliverables either on scheduled or adhoc basis
- Experience with producing outputs submitted to the FDA and other regulatory agencies
- Excellent organizational skill to prioritize multiple tasks and goals to ensure timely completion
- Attention to detail and able to adapt to a fast-paced environment
- Ability to work both independently and in a cross-functional team
- Excellent communication skills
- Sufficient knowledge in CDISC and SDTM/ADAM for FDA submission compliance
- Adequate knowledge in clinical trial research methodology, ICH, GCP and regulations
- Experiences in medical device and cardiovascular disease is desirable, but not required
