Principal Programmer– CDISC Compliance & FDA Submission Conformance Consultant (Remote)

Summary: The Principal Programmer role focuses on ensuring compliance with CDISC standards and FDA submission requirements in a remote capacity. The position involves working on statistical programming and data analysis for regulatory submissions. The candidate will collaborate with cross-functional teams to deliver high-quality programming solutions. This role is contract-based and requires expertise in programming and compliance within the biotech or pharmaceutical industry.

Key Responsibilities:

• Ensure compliance with CDISC standards for regulatory submissions.
• Develop and validate statistical programs for data analysis.
• Collaborate with cross-functional teams to meet project deadlines.
• Provide programming support for FDA submissions.

Key Skills:

• Expertise in statistical programming languages (e.g., SAS).
• Strong understanding of CDISC standards and FDA submission processes.
• Experience in the biotech or pharmaceutical industry.
• Ability to work independently in a remote environment.

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other