Programming Contractor

This is a fully remote position, open to applicants in United States.

📋 Description

• Create, validate, and sustain SAS programming outputs that support analysis and reporting of clinical studies.

• Program and validate tables, listings, figures, and derived datasets utilizing SAS.

• Develop specifications, datasets, and supporting documentation for SDTM and ADaM.

• Prepare and review mapping specifications, annotated case report forms, define, SDRG, ADRG, and various submission files.

• Conduct quality control and validation processes for programming outputs.

• Collaborate with team members to identify, investigate, and resolve data and output discrepancies.

• Review study documents and provide feedback to enhance programming quality, efficiency, and consistency.

• Ensure all programming documentation is complete, accurate, and ready for audits or inspections.

• Communicate project status, risks, issues, and any impacts on timelines to stakeholders.

• Execute additional duties as assigned.

⛳️ Requirements

• A Bachelor’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field is required.

• At least 10 years of relevant experience in statistical programming within the pharmaceutical, biotechnology, or CRO sectors.

• Proficient SAS programming skills, with experience in developing SDTM, ADaM, tables, listings, and figures.

• Comprehensive understanding of clinical trial processes, regulatory requirements, and programming documentation.

• Exceptional attention to detail, along with strong analytical, problem-solving, and communication abilities.

• Capability to work independently and manage multiple priorities in a fast-paced, deadline-oriented environment.

• Experience in Phase 3 and regulatory submissions is a plus.

• Candidates must be eligible to work in the United States without requiring work visa or residency sponsorship.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Retirement plans with company matching contributions.

• Opportunities for professional development and continuing education.

• Flexible work arrangements and a supportive work environment.