Principal Scientist, Biostatistics

• Provide input to the design and execution of studies and experiments for Clinical Development, Medical Affairs, Discovery, and Manufacturing Sciences programs
• Support statistical analysis, interpretation, reporting, and communication of data evidence
• Collaborate with Quantitative Sciences & Clinical Pharmacology and other drug development scientists
• Support statistical aspects of business and regulatory commitments
• Contribute to program plans and represent Statistics & Decision Sciences in teams and working groups
• Apply advanced data analytics and high-quality statistical methodologies
• Use computational tools, innovative data-adaptive methods, and artificial intelligence
• Optimize study designs, conduct scenario simulations, and perform sample size calculations
• Identify and implement advanced statistical techniques for complex projects
• Provide leadership and guidance on study and trial design
• Collaborate cross-functionally to identify and resolve issues
• Engage in process improvement and standards development
• Build partnerships with internal colleagues, CROs, consultants, and other external partners
• Deliver high-quality and timely outputs to project and clinical trial teams and the Statistics Area Head
• Track external scientific and statistical trends and advance methodologies through scholarly publications
• Participate in interactions with health authorities

• Minimum of a Master's degree with 6+ years of relevant experience, or a PhD with 4+ years of relevant experience
• Proficiency in SAS, R programming, or other relevant computational tools such as East Horizon, RPACT, FACTS, or Python
• Excellent interpersonal, verbal, and written communication skills
• Demonstrated ability to work in interdisciplinary contexts outside statistics

Expertise in statistical analysis, advanced data analytics, and study design is essential, along with proficiency in SAS, R programming, and other computational tools. Strong communication and collaboration skills are necessary for effective cross-functional teamwork and leadership in clinical development.

• Statistical Analysis
• SAS Programming
• R Programming
• Advanced Data Analytics
• Study Design Optimization

• Statistical Methodologies
• Sample Size Calculations
• Data-Adaptative Methods
• Scenario Simulations
• Statistical Techniques

• Interpersonal Skills
• Verbal Communication
• Written Communication
• Collaboration

• Clinical Development
• Medical Affairs
• Quantitative Sciences
• Regulatory Commitments
• Process Improvement

• East Horizon
• RPACT
• FACTS
• Python