Job Description

• 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.

• 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 industry
• Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials
• Proficiency 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) preferred
• Experience with implementing CDISC standards preferred.
• bility to work effectively on cross-functional teams.
• Effective communication skills with all levels of management and organizations
• Operates both as a team and independently, with adaptability to changing requirements.

Job Tags

Similar Jobs