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Clinical Data Analyst

2 months ago

Houston, Texas, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities

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.

Statistical Programming

You will be responsible for the 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.

Analysis and Reporting

As a Clinical SAS Programmer, you will write and validate SAS programs to generate tables, listings, and figures (TLFs) for clinical study reports and analysis datasets. You will also lead the statistical programming thinking, analysis, and reporting to relevant groups in product and study teams.

Requirements

To be successful in this role, you will need a B.S. degree in statistics, computer science, mathematics, or a related area, 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 with 3+ years of experience will also be considered.

You will also need working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials. Proficiency in SAS, including the use of statistical procedures such as nonparametric analysis, linear and non-linear models, categorical data, and survival analysis, is required. SAS certification is preferred.

Experience with analysis of medical device trials for PMA or 510(k) and implementation of CDISC standards is also desirable. You will need to be able to work effectively on cross-functional teams and possess effective communication skills with all levels of management and organizations.