Freelance - Biostatistical Programmer

About the Role:
A leading global pharmaceutical company is seeking an experienced freelance biostatistical programmer to support a pivotal Phase 3 clinical trial. This is a contract-based opportunity ideal for professionals with strong statistical programming skills and prior submission experience.

Key Responsibilities:

• Support the integration of new trial data into an existing pooled analysis dataset.
• Create and validate statistical outputs including tables, figures, and listings (TFLs).
• Perform quality control (QC) of programming documentation and outputs.
• Develop and maintain ADaM datasets in compliance with CDISC standards.
• Collaborate with cross-functional teams to ensure readiness for regulatory submission.

Required Skills & Experience:

• Proven experience in Phase 3 clinical trials, ideally within large pharma or CRO environments.
• 5-10 years experience working with a pharmaceutical company
• Proficiency in SAS and R for statistical programming.
• Strong working knowledge of ADaM datasets and CDISC standards.
• Experience with regulatory submissions (e.g., FDA, EMA).
• Ability to work independently and manage timelines effectively.

Preferred Qualifications:

• Advanced degree (MSc or PhD) in Biostatistics, Statistics, or a related field preferred.
• Familiarity with clinical trial data standards and documentation best practices.