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 security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Associate Director Statistics, Consultant to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Job Summary
We are seeking an experienced Associate Director, Statistics to provide study-level statistical leadership for late-phase Hematology oncology programs. This role will support studies within eR&I / V&I / NS and requires sufficient pharmaceutical industry experience to independently lead statistical activities within drug development projects. The successful candidate will partner closely with cross-functional teams and contribute to high-quality, submission-ready deliverables.
Responsibilities
• Provide study-level statistical support for late-phase Hematology oncology studies
• Serve as the lead statistician on assigned studies and contribute to overall program strategy
• Independently plan, execute, and oversee statistical activities across the study lifecycle
• Ensure statistical deliverables meet quality, timeline, 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
• Provide oversight 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 complex statistical concepts clearly 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 related field
• Significant experience as a statistician in the pharmaceutical industry
• Late-phase oncology experience, with a strong focus on Hematology
• Proven ability to independently lead statistical work within drug development projects
• Hands-on experience supporting clinical trials at the study level
• Strong written and verbal communication skills
Nice-to-haves
• Experience supporting regulatory submissions (FDA/EMA)
• Prior experience leading or mentoring junior statisticians
• Experience working in cross-functional and global teams
Apply Now
Apply Now
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Associate Director Statistics, Consultant to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Job Summary
We are seeking an experienced Associate Director, Statistics to provide study-level statistical leadership for late-phase Hematology oncology programs. This role will support studies within eR&I / V&I / NS and requires sufficient pharmaceutical industry experience to independently lead statistical activities within drug development projects. The successful candidate will partner closely with cross-functional teams and contribute to high-quality, submission-ready deliverables.
Responsibilities
• Provide study-level statistical support for late-phase Hematology oncology studies
• Serve as the lead statistician on assigned studies and contribute to overall program strategy
• Independently plan, execute, and oversee statistical activities across the study lifecycle
• Ensure statistical deliverables meet quality, timeline, 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
• Provide oversight 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 complex statistical concepts clearly 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 related field
• Significant experience as a statistician in the pharmaceutical industry
• Late-phase oncology experience, with a strong focus on Hematology
• Proven ability to independently lead statistical work within drug development projects
• Hands-on experience supporting clinical trials at the study level
• Strong written and verbal communication skills
Nice-to-haves
• Experience supporting regulatory submissions (FDA/EMA)
• Prior experience leading or mentoring junior statisticians
• Experience working in cross-functional and global teams
Apply Now
Apply Now