Address
Form of work Responsibilities:
- Utilize SAS to generate and validate tables, listings, and figures (TLF) based on SAP.
- Use major statistical programming language to perform data analysis for various needs.
- Provide statistical analysis support for post approval studies.
- Evaluate and ensure CDISC compliance of study tabulation and analysis data files.
- Write specifications and statistical programs to generate analysis datasets and outputs.
- Perform data analysis tasks with minimal supervision.
- Provide programming support for data management.
- Develop statistical toolbox for advanced data modelling, tabulation, and visualization.
- Participate in reviewing and validating data analysis results.
- Strong SAS programing skill in producing various types of outputs such as TLFs and datasets with minimum of 3 years of experiences.
- Extensive statistical programming experience in producing deliverables either on scheduled or ad hoc basis.
- BS degree in Statistics, Mathematics, Computer Science, or related field, MS in Statistics or Biostatistics is preferred.
- 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
