Senior Statistician

🌟 Job Overview

We are seeking a forward-thinking Statistical Scientist to join our R&D team and play a key role in designing, analyzing, and interpreting clinical and non-clinical data for drug development. This individual will work across multidisciplinary teams to ensure statistically robust and regulatory-compliant methods that support our mission of advancing innovative therapies for patients worldwide.

🔬 Key Responsibilities

• Design statistically sound clinical trials (Phase I–IV) and ensure alignment with regulatory requirements
• Develop and validate statistical analysis plans, including complex modeling and simulation approaches
• Perform data analyses and interpret results to inform decision-making across drug development stages
• Collaborate with Clinical Operations, Regulatory Affairs, and Data Management teams to maintain data integrity
• Provide statistical input to study protocols, investigator brochures, and submission dossiers
• Contribute to publications, presentations, and regulatory interactions (e.g., with EMA, MHRA, FDA)
• Maintain knowledge of current statistical methodologies, regulatory expectations, and industry trends
• Mentor junior statisticians and promote statistical excellence across the organization

📚 Qualifications & Experience

• PhD or Master’s degree in Biostatistics, Statistics, or related quantitative discipline
• 3+ years experience in pharmaceutical or biotechnology industry, preferably in clinical trial statistics
• Proficiency in statistical software (SAS, R, or Python) and relevant CDISC standards (SDTM, ADaM)
• Deep understanding of ICH guidelines, GCP, and statistical regulatory frameworks
• Strong written and verbal communication skills with ability to translate data into strategic insights
• Experience supporting regulatory submissions and health authority interactions is a plus