Freelance Biostatistical Programmer (m/f/d)

About the Role: A leading global pharmaceutical company is seeking an experienced Freelance Biostatistical Programmer at (0.8-1FTE) to support a pivotal Phase 3 clinical trial. This is a 6-12 month 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 for 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.