Katalyst Healthcares and Life Sciences
Clinical SAS Programmer
Katalyst Healthcares and Life Sciences, Houston, Texas, United States, 77246
Responsibilities:
Participate in the execution of global studies for regulatory submissions, reimbursement, and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management.Statistical programming of deliverables for regulatory submissions, including detailed and systematic specification of study variables, outputs, and response to regulatory questions.Develop SAS macros, templates and utilities for data reporting and visualization.Write and validate SAS programs to generate tables, listings, and figures (TLFs) for clinical study reports and analysis datasets.Proactively seek out and follow best practices in programming documentation.Lead the statistical programming thinking, analysis, and reporting to relevant groups in product and study teams. Other duties as assigned.Requirements:
B.S. degree in statistics, computer science, mathematics or related areas and 5+ years of direct and related experience in medical device, pharmaceutical, biotechnology industry or a master's degree in Biostatistics or Epidemiology and 3+ years of direct and related experience in medical device, pharmaceutical, biotechnology industryWorking knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trialsProficiency in SAS includes the use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data, and survival analysis required. SAS certification preferred.Experience with analysis of medical device trials for PMA or 510(k) preferredExperience with implementing CDISC standards preferred.bility to work effectively on cross-functional teams.Effective communication skills with all levels of management and organizationsOperates both as a team and independently, with adaptability to changing requirements.
Participate in the execution of global studies for regulatory submissions, reimbursement, and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management.Statistical programming of deliverables for regulatory submissions, including detailed and systematic specification of study variables, outputs, and response to regulatory questions.Develop SAS macros, templates and utilities for data reporting and visualization.Write and validate SAS programs to generate tables, listings, and figures (TLFs) for clinical study reports and analysis datasets.Proactively seek out and follow best practices in programming documentation.Lead the statistical programming thinking, analysis, and reporting to relevant groups in product and study teams. Other duties as assigned.Requirements:
B.S. degree in statistics, computer science, mathematics or related areas and 5+ years of direct and related experience in medical device, pharmaceutical, biotechnology industry or a master's degree in Biostatistics or Epidemiology and 3+ years of direct and related experience in medical device, pharmaceutical, biotechnology industryWorking knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trialsProficiency in SAS includes the use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data, and survival analysis required. SAS certification preferred.Experience with analysis of medical device trials for PMA or 510(k) preferredExperience with implementing CDISC standards preferred.bility to work effectively on cross-functional teams.Effective communication skills with all levels of management and organizationsOperates both as a team and independently, with adaptability to changing requirements.