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.