Job Description
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 shellsStatistical 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
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Apply Now