Associate Director,Statistics- Consulting -Hematology- (REMOTE @ US)

ClinChoice

6h•Remote

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. Role Overview We are seeking a Consulting Associate Director, Statistics with strong experience in hematology to provide strategic and hands-on statistical leadership across clinical development programs. This role partners closely with clinical, regulatory, programming, and data management teams to ensure high-quality statistical deliverables that support study execution and global submissions. The ideal candidate brings deep therapeutic expertise, prior regulatory submission experience, and the ability to operate independently in a fast-paced, matrixed environment. Role Overview We are seeking a Consulting Associate Director, Statistics with strong experience in hematology to provide strategic and hands-on statistical leadership across clinical development programs. This role partners closely with clinical, regulatory, programming, and data management teams to ensure high-quality statistical deliverables that support study execution and global submissions. The ideal candidate brings deep therapeutic expertise, prior regulatory submission experience, and the ability to operate independently in a fast-paced, matrixed environment.

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.

Responsibilities

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.