Statistical Programmer Consultant
Work Location: Remote

Summary:

The Statistical Programmer Consultant will contribute to programming activities across multiple studies, ensuring the creation and validation of datasets and outputs in compliance with industry standards. This role requires collaboration with cross-functional teams and the application of technical expertise to support project deliverables and process improvements.

Responsibilities:

• Participate in programming tasks for several concurrent projects and studies.
• Review and annotate case report forms for mapping to standardized data models, and generate and validate datasets according to regulatory requirements.
• Develop and review specifications for analysis datasets.
• Independently program and validate tables, figures, and listings using statistical software.
• Collaborate with biostatistics, data management, and other functional teams to achieve project goals and timelines.
• Offer technical feedback on documents produced by other departments.
• Identify opportunities and support the development of new tools to enhance efficiency and quality.
• Ensure compliance with submission standards and contribute to regulatory documentation.

Qualifications:

• 8+ years of experience as a statistical programmer in the biotech or pharmaceutical industry.
• BS or MS degree in Statistics, Biostatistics, Computer Science, or Engineering (MS preferred).
• Proficiency in CDISC SDTM/ADaM programming.
• Extensive experience with SAS for creating complex tables, listings, and figures.
• Direct experience with electronic submission processes for regulatory agencies.
• Familiarity with creating Define.xml and reviewer’s guides.
• Strong communication skills and ability to work independently with supervision.

Published Category: Data Management & Programming