Associate Director, Statistics – Consulting – Hematology

Job reputed company: • 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. Requirements: • 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. Benefits: • Health insurance • reputed company development Apply tot his job Apply To this Job