Associate Director, Statistics – Consulting – Hematology
Job Description:
• Lead statistical strategy for hematology studies across phases of development.
• Provide input into protocol design, study endpoints, estimands, and analysis methods.
• Author and review statistical sections of protocols, SAPs, and other key documents.
• Ensure alignment with regulatory expectations and industry standards.
• Oversee generation and validation of TLFs and other statistical outputs.
• Guide programming teams on analysis requirements and quality expectations.
• Interpret study results and provide statistical insights to cross-functional teams.
• Contribute to IND, NDA/BLA, and other global submissions.
• Participate in regulatory interactions, health authority questions, and responses.
• Work closely with Clinical Development, Medical, Data Management, and Programming.
• Provide mentorship and technical guidance to statisticians and programmers.
• Ensure adherence to SOPs, CDISC standards, and regulatory guidance.
• Promote efficient, reproducible, and high-quality statistical practices.
Requirements:
• MS or PhD in Statistics or Biostatistics.
• Significant industry experience in clinical trial statistics.
• Strong experience within hematology (oncology/hem-onc highly preferred).
• Proven track record supporting regulatory submissions.
• Solid understanding of CDISC, ICH, and global regulatory requirements.
• Ability to work independently in a consulting/FSP environment.
• Strong communication and stakeholder management skills.
Benefits:
• Health insurance
• Professional development
Apply Now
Apply Now
• Lead statistical strategy for hematology studies across phases of development.
• Provide input into protocol design, study endpoints, estimands, and analysis methods.
• Author and review statistical sections of protocols, SAPs, and other key documents.
• Ensure alignment with regulatory expectations and industry standards.
• Oversee generation and validation of TLFs and other statistical outputs.
• Guide programming teams on analysis requirements and quality expectations.
• Interpret study results and provide statistical insights to cross-functional teams.
• Contribute to IND, NDA/BLA, and other global submissions.
• Participate in regulatory interactions, health authority questions, and responses.
• Work closely with Clinical Development, Medical, Data Management, and Programming.
• Provide mentorship and technical guidance to statisticians and programmers.
• Ensure adherence to SOPs, CDISC standards, and regulatory guidance.
• Promote efficient, reproducible, and high-quality statistical practices.
Requirements:
• MS or PhD in Statistics or Biostatistics.
• Significant industry experience in clinical trial statistics.
• Strong experience within hematology (oncology/hem-onc highly preferred).
• Proven track record supporting regulatory submissions.
• Solid understanding of CDISC, ICH, and global regulatory requirements.
• Ability to work independently in a consulting/FSP environment.
• Strong communication and stakeholder management skills.
Benefits:
• Health insurance
• Professional development
Apply Now
Apply Now