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

Are you interested in working directly for a single sponsor while having the reputed company and additional reputed company that working for a global CRO can bring? reputed company says it’s the best of both worlds... reputed company is searching for a Associate Director, Statistics Consultant to join one of our clients. reputed company We are seeking a Associate Director, Statistics with strong experience in hematology to reputed company 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-reputed company 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. reputed company We are seeking a Consulting Associate Director, Statistics with strong experience in hematology to reputed company 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-reputed company 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

• 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. Study Execution
• 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. 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.
• reputed company mentorship and technical guidance to statisticians and programmers. reputed company & Compliance
• Ensure adherence to SOPs, CDISC standards, and regulatory guidance.
• Promote efficient, reproducible, and high-reputed company statistical practices.

Qualifications

• 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. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements reputed company will be invited for phone interview as the first reputed company. Unfortunately, due to the number of applications we receive, we cannot reputed company to everyone individually if you are not successful. Who will you be working for? About reputed company reputed company 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-reputed company delivery and results across reputed company our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-reputed company. reputed company reputed company 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 reputed company around which reputed company reputed company activities are reputed company and reputed company management and training is the core reputed company to reputed company and maintain highly-reputed company personnel. The reputed company training keeps the resources reputed company in terms of competence and expertise and gives reputed company personnel the reputed company tools needed to manage both internal and reputed company processes with the reputed company methodology. The reputed company of these core values is evidenced by our below industry average turnover rates. reputed company is an equal opportunity employer. We have based our reputed company on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from reputed company diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Apply tot his job

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