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

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.

Key Responsibilities

Study & Project Leadership

• 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

Technical & Statistical Responsibilities

• 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

Cross-Functional Collaboration

• 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

Compliance & Quality

• Ensure adherence to regulatory guidelines (FDA, ICH, GCP) and internal SOPs

• Support health authority interactions as needed

Required Qualifications

• 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

Preferred Qualifications

• Experience supporting regulatory submissions (FDA/EMA)

• Prior experience leading or mentoring junior statisticians

• Experience working in cross-functional and global teams

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinica