Principal Biostatistician

About the Role As a Principal Biostatistician, you will provide project leadership in Biostatistics for specific company products or therapeutic areas, develop standards across protocols, review study setup activities, and lead multiple projects. You will perform statistical analyses, interpret results, and prepare clinical study reports, including integrated summaries for submissions, while addressing regulatory issues and collaborating with external development partners. What You'll Do

• Manage a moderate or large volume of complex tasks with minimal supervision across one or more drug programs.
• Proactively assess and adapt solutions for the Biometrics department, resolving technical issues.
• Make decisions at the study level across various studies, leading and prioritizing tasks globally.
• Collaborate closely with clinical research, regulatory affairs, CROs, Commercial, Worldwide Medical, KOLs, and other disciplines.
• Monitor needs and determine resources in consultation with line managers.
• Participate in organization-wide initiatives such as quality and standardization efforts. What We're Looking For
• Detail-oriented and analytical with strong leadership and communication skills; ability to work collaboratively and proactively.
• PhD in Biostatistics/Statistics or equivalent with 0+ years relevant experience, or MS with 3+ years relevant experience.
• Thorough understanding of statistical principles and clinical trial methodology.
• Ability to provide innovative and practicable technical solutions.
• Working knowledge of medical/biological terminology and clinical trial designs.
• Proficiency in writing and presenting information effectively.
• Conversant with SAS programming and detailed knowledge of statistical software.
• Working knowledge of regulatory guidelines and needs for statistical analysis.
• Demonstrated leadership and communication skills. Nice to Have
• Experience in global-scale task management and decision-making.
• Familiarity with organization-wide initiatives such as quality and standardization.
• Ability to interact with KOLs and collaborators across different disciplines. Compensation & Benefits
• Base salary range: $123,000.00-$163,000.00 USD per year.
• The base salary offered is determined through an analytical approach considering skills, experience, location, and internal equity.