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Associate Director,Statistics- Consulting -Hematology- (REMOTE @ US) jobs in United States
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ClinChoice · 1 day ago

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

positionUnited States
timeFull-time
remoteRemote
seniorityLead/Staff, Director/Executive
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They are seeking an Associate Director, Statistics to provide strategic and hands-on statistical leadership across clinical development programs, particularly in hematology, ensuring high-quality statistical deliverables for regulatory submissions.
BiotechnologyConsultingHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

StatisticsHematologyRegulatory submissionsCDISC standardsStakeholder managementCommunication skillsIndependent work

Required

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

Company

ClinChoice

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ClinChoice is a Reaserch and Deveiopment platform that develops innovative drugs and devices.
dateFounded in 1995
location
Shanghai, Shanghai, CHN
people-size1001-5000 employees
web-link
https://www.clinchoice.com.cn

H1B Sponsorship

ClinChoice has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (28)
2023 (21)
2022 (25)
2021 (35)
2020 (3)

Funding

Current Stage
Late Stage
Total Funding
$212M
Key Investors
Legend CapitalGoldman Sachs,Lilly Asia VenturesGoldman Sachs
2022-07-04Series E· $150M
2019-10-25Series D· $62M
2019-05-01Series C

Leadership Team

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John Balian, MD
Chief Executive Officer
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Recent News

PharmiWeb
ClinChoice Earns Global ISO 9001:2015 and ISO 14155:2020...
2025-11-18
PharmiWeb.com
ClinChoice Acquires CROMSOURCE, Solidifying its Position Globally
2023-07-18
Bloomberg.com
Goldman-Backed ClinChoice Considers Hong Kong IPO
2023-07-07
Company data provided by crunchbase