Clinical Data Analyst
3 weeks ago
As a Clinical SAS Programmer at Katalyst Healthcares and Life Sciences, you will play a crucial role in the execution of global studies for regulatory submissions, reimbursement, and product adoption. Your expertise will be utilized in the development of clinical study documents, study implementation, and data management.
You will be responsible for statistical programming of deliverables for regulatory submissions, including the specification of study variables, outputs, and responses to regulatory questions. Additionally, you will develop SAS macros, templates, and utilities for data reporting and visualization.
Your duties will also include writing and validating SAS programs to generate tables, listings, and figures for clinical study reports and analysis datasets. You will be expected to proactively seek out and follow best practices in programming documentation.
As a leader in statistical programming, you will be responsible for guiding the statistical programming thinking, analysis, and reporting to relevant groups in product and study teams.
Requirements:
B.S. degree in statistics, computer science, mathematics, or a related field, and 5+ years of direct and related experience in the medical device, pharmaceutical, or biotechnology industry. Alternatively, a master's degree in Biostatistics or Epidemiology and 3+ years of direct and related experience in the medical device, pharmaceutical, or biotechnology industry.
Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials is required. Proficiency in SAS, including the use of statistical procedures such as nonparametric analysis, linear and non-linear models, categorical data, and survival analysis, is also required. SAS certification is preferred.
Experience with analysis of medical device trials for PMA or 510(k) and implementation of CDISC standards is preferred. The ability to work effectively on cross-functional teams and communicate effectively with all levels of management and organizations is essential.
Operates both as a team and independently, with adaptability to changing requirements.
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