Overview

Oracle Life Sciences is seeking an experienced Lead Biostatistician - Statistical Programming to join our innovative team in the United Kingdom. In this pivotal role, you will lead statistical programming efforts for clinical trials, ensuring high-quality data analysis and reporting. Drive cutting-edge solutions in life sciences with Oracle's advanced platforms.

Responsibilities

• Lead the development and validation of SAS programs for statistical analyses in clinical trials.
• Oversee CDISC standards implementation for SDTM and ADaM datasets.
• Collaborate with biostatisticians to generate Tables, Listings, and Figures (TLFs).
• Manage programming team, providing mentorship and ensuring project timelines are met.
• Review and approve statistical analysis plans and programming deliverables.
• Ensure compliance with regulatory guidelines (FDA, EMA) and GCP standards.
• Develop and maintain programming documentation and SOPs.
• Support ad-hoc analyses and contribute to publications and regulatory submissions.

Qualifications

• Advanced degree (MSc/PhD) in Biostatistics, Statistics, or related field.
• 8+ years of experience in statistical programming within pharma/biotech.
• Expertise in SAS programming (Base SAS, Macro, STAT) required.
• Strong knowledge of CDISC standards and clinical trial data structures.
• Proven leadership experience in managing programming teams.
• Excellent communication skills and experience with regulatory submissions.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Generous pension scheme and life assurance.
• Flexible working arrangements and hybrid model.
• Professional development opportunities and Oracle certification programs.