ClinChoice

Associate Director, Statistics – Consulting – Hematology

ClinChoice

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
statistical strategyprotocol designstudy endpointsestimandsanalysis methodsTLFs generationstatistical outputsregulatory submissionsSOPs adherenceCDISC standards
Soft Skills
mentorshiptechnical guidancecommunicationstakeholder managementindependent workcross-functional collaborationquality expectationsstatistical insightsconsulting skillsleadership
Certifications
MS in StatisticsPhD in Biostatistics