Job Description

Responsibilities: 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 Requirements: 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 Katalyst Healthcares and Life Sciences

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