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

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds... ClinChoice is searching for a Associate Director, Statistics Consultant to join one of our clients. Role Overview We are seeking a Associate Director, Statistics with strong experience in hematology to provide strategic and hands-on statistical leadership across clinical development programs. This role partners closely with clinical, regulatory, programming, and data management teams to ensure high-quality statistical deliverables that support study execution and global submissions. The ideal candidate brings deep therapeutic expertise, prior regulatory submission experience, and the ability to operate independently in a fast-paced, matrixed environment. Role Overview We are seeking a Consulting Associate Director, Statistics with strong experience in hematology to provide strategic and hands-on statistical leadership across clinical development programs. This role partners closely with clinical, regulatory, programming, and data management teams to ensure high-quality statistical deliverables that support study execution and global submissions. The ideal candidate brings deep therapeutic expertise, prior regulatory submission experience, and the ability to operate independently in a fast-paced, matrixed environment.

Key Responsibilities

Statistical Leadership

• 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. Study Execution
• 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. Regulatory Support
• Contribute to IND, NDA/BLA, and other global submissions.
• Participate in regulatory interactions, health authority questions, and responses. Collaboration
• Work closely with Clinical Development, Medical, Data Management, and Programming.
• Provide mentorship and technical guidance to statisticians and programmers. Quality & Compliance
• Ensure adherence to SOPs, CDISC standards, and regulatory guidance.
• Promote efficient, reproducible, and high-quality statistical practices.

Qualifications

• 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. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Apply tot his job

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