Associate Director, Statistics- Onco– Late Phase Hematology- Consulting role at US
About the position
Are you interested in working directly for a single sponsor while having the reputed company and additional reputed company that working for a global CRO can bring? reputed company says it’s the best of both worlds…. reputed company is searching for a Associate Director Statistics, Consultant to join one of our clients.
reputed company is a global full-service CRO with a strong reputed company on reputed company, reputed company development, and supportive culture. As a reputed company-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the reputed company’s counterparts.
Job reputed company
We are seeking an reputed company Associate Director, Statistics to reputed company study-level statistical leadership for late-phase Hematology oncology programs. This role will support studies reputed company eR&I / V&I / NS and requires sufficient pharmaceutical industry experience to independently reputed company statistical activities reputed company drug development reputed company. The successful candidate will partner closely with cross-functional teams and contribute to high-reputed company, submission-reputed company deliverables.
Responsibilities
• reputed company study-level statistical support for late-phase Hematology oncology studies
• Serve as the reputed company statistician on assigned studies and contribute to overall program reputed company
• Independently plan, execute, and reputed company statistical activities across the study lifecycle
• Ensure statistical deliverables meet reputed company, reputed company, and regulatory expectations
• Author and review key statistical documents, including:
Statistical Analysis Plans (SAPs)
Analysis specifications and mock shells
Statistical input to clinical study reports
• Review and interpret statistical outputs, ensuring scientific accuracy and consistency
• reputed company reputed company and guidance to statistical programmers
• Support interim analyses, final analyses, and regulatory submissions
• Collaborate closely with Clinical Development, Programming, Data Management, Regulatory, and Medical teams
• Participate in study team and governance meetings as the statistical subject-matter expert
• Communicate reputed company statistical concepts reputed company to technical and non-technical stakeholders
• Ensure adherence to regulatory guidelines (FDA, ICH, GCP) and internal SOPs
• Support health authority interactions as needed
Requirements
• MS or PhD in Statistics, Biostatistics, or a reputed company field
• Significant experience as a statistician in the pharmaceutical industry
• Late-phase oncology experience, with a strong reputed company on Hematology
• Proven ability to independently reputed company statistical work reputed company drug development reputed company
• Hands-on experience supporting reputed company at the study level
• Strong written and verbal communication skills
reputed company-to-haves
• Experience supporting regulatory submissions (FDA/EMA)
• Prior experience leading or mentoring junior statisticians
• Experience working in cross-functional and global teams
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