Sr R & SAS Programmer

Responsibilities

• Program and validate derived datasets, tables, figures, listings.
• Process data from external sources.
• Perform ad hoc exploratory analyses for publications and provide programming support for other functions within Research and Development or other organizations.
• Oversee programming work/deliverables from Contract Research Organizations (CROs).
• Contribute to the design, implementation, and review of Case Report Forms (CRFs), Data Transfer Specifications (DTS), Statistical Analysis Plans (SAP), and SDTM/ADaM specifications.
• Define packages and ensure compliance with CDISC standards for electronic submissions.
• Support in the creation of supporting documentation for regulatory submissions.
• Ensure that programming deliverables are completed on time and meet high quality standards.
• Manage internal contractors and external vendors.
• Participate in the development of departmental working instructions and guidelines.
• Create enhanced functions and utilities as needed.

Requirements

• Bachelor or Master’s degree in Computer Science, Mathematics, Engineering, Medical, or a related field.
• At least 5 years of experience in statistical programming (SAS, R) in the pharmaceutical industry, or a Master’s degree with at least 3 years of experience.
• Working knowledge of SAS and its various components.
• Knowledge of R programming in clinical trials.
• Familiarity with the drug development process.
• Knowledge of CDISC standards and electronic submission requirements.
• Strong SAS and SAS Macro language skills.
• R programming skills in clinical trials.
• Strong knowledge of industry standards.
• Ability to work on data integrations (ISS and ISE).
• Strong oral and written communication skills.
• Ability to communicate complex analysis details to non-technical team members.
• Ability to manage multiple projects and timelines effectively.