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Associate Director, Statistics- Onco– Late Phase Hematology- Consulting role at US

Remote, USA Full-time Posted 2025-11-24
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 tot his job Apply To this Job

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