Job Description
Job Description: • 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. 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. Benefits: • Health insurance • Professional development Apply tot his job Apply tot his job
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