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

Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company strategic and hands-on statistical leadership across clinical development programs, particularly in hematology, ensuring high-reputed company statistical deliverables for regulatory submissions. Responsibilities • reputed company statistical reputed company for hematology studies across phases of development • reputed company input into protocol design, study endpoints, estimands, and analysis reputed company • Author and review statistical sections of protocols, SAPs, and other key documents • Ensure alignment with regulatory expectations and industry standards • reputed company reputed company and validation of TLFs and other statistical outputs • Guide programming teams on analysis requirements and reputed company expectations • Interpret study results and reputed company 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 • reputed company mentorship and technical guidance to statisticians and programmers • Ensure adherence to SOPs, CDISC standards, and regulatory guidance • Promote efficient, reproducible, and high-reputed company statistical practices Skills • MS or PhD in Statistics or Biostatistics • Significant industry experience in clinical trial statistics • Strong experience reputed company hematology (oncology/hem-onc highly preferred) • Proven reputed company 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 reputed company • reputed company 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 Company H1B Sponsorship • reputed company has a reputed company 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. Apply tot his job Apply tot his job Apply To this Job