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

Note: The job is a remote job and is open to candidates in USA. ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They are seeking an Associate Director, Statistics to provide strategic and hands-on statistical leadership across clinical development programs, particularly in hematology, ensuring high-quality statistical deliverables for regulatory submissions.

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

Skills
• 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

Company Overview
• ClinChoice is a Reaserch and Deveiopment platform that develops innovative drugs and devices. It was founded in 1995, and is headquartered in Shanghai, Shanghai, CHN, with a workforce of 1001-5000 employees. Its website is https://www.clinchoice.com.cn.

Company H1B Sponsorship
• ClinChoice has a track record of offering H1B sponsorships, with 20 in 2025, 28 in 2024, 21 in 2023, 25 in 2022, 35 in 2021, 3 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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