Clinical SAS Programmer

• Lead projects with higher level of complexity/challenges/difficulties. Lead efforts to resolve complex statistical programming issues or problems.
• Assist statistical programming management in properly planning and allocating resources based on timelines, statistical programmers' skills, and expertise, as well as availability.
• Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements.
• Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
• Monitor the compliance and adherence to the established data and programming standards, and statistical programming governing documents.
• May represent the company in interactions with clinical trial sponsors regarding statistical programming projects and relevant businesses.
• Participate in the development of statistical programming policies, SOPs, guidelines, and good working practices.
• Participate in statistical programming project bidding or bid defense meetings.

Requirements:

• Experience providing programming leadership and support to clinical trials in the life science industry, ideally in a CRO.
• Master's or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
• Strong proficiency implementing the latest CDISC SDTM / ADaM standards.
• An in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies.
• Must be able to demonstrate an ability to effectively plan, control, and carry-on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies.