Statistical Programmer

Job Summary:

We are seeking a highly skilled Statistical Programmer to participate in developing and maintaining clinical trial data and statistical programming standards.

Responsibilities:

1. Develop and maintain clinical trial data and statistical programming standards to ensure company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements.
2. Perform hands-on primary statistical programming and validation programming on assigned projects, including phase I – IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc.
3. Create SDTM mapping specifications and ADaM data specifications.
4. Perform quality control (QC) review of documents prepared by others, including SDTM and ADaM define.xml files.
5. Perform 3rd level QC review on programming deliverables before their release to clients.
6. Perform QC review/assessment on regulatory submission programming documents, datasets, tables/listings/graphs (TLGs), and computer programs, etc.
7. Lead programming efforts for drug development programs or assigned client clusters.
8. Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
9. Participate in statistical programming project bidding or bid defense meetings.
10. Work with document management specialists/archivists to plan and perform archival of the statistical programming datasets, outputs, documents, and final programs upon the completion of assigned projects.
11. Transfer archived files to clinical trial sponsors.

Requirements:

• M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
• 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.
• Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented.
• Knowledge of clinical trial regulatory and ICH requirements.
• Demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies.
• Sound technical judgment and experience in process design and implementation in relevant areas.
• Strong leadership and drive to achieve goals will be required.

Estimated Salary: $120,000 - $150,000 per year, depending on experience.