Senior Statistical Programmer/Analyst Consultant- Oncology (require -BLA Submission and Macro) jobs in United States
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ClinChoice · 2 hours ago

Senior Statistical Programmer/Analyst Consultant- Oncology (require -BLA Submission and Macro)

positionUnited States
timeFull-time
remoteRemote
senioritySenior Level
date7+ years exp

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions. They are seeking a Senior Statistical Programmer Consultant to provide Phase III study support for BLA submissions, requiring strong SAS programming skills and collaboration with biostatistics and clinical teams.

BiotechnologyConsultingHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Perform end-to-end SAS programming for Phase III clinical trials
Develop and validate SDTM, ADaM datasets, TLFs in compliance with CDISC standards
Support BLA submissions, including regulatory-ready deliverables
Design, develop, and maintain complex SAS macros to improve efficiency and standardization
Collaborate closely with biostatisticians, data management, and cross-functional teams
Ensure programming deliverables meet quality, timelines, and regulatory expectations
Participate in programming reviews, QC activities, and issue resolution

Qualification

SAS programmingMacro developmentBLA submissionsCDISC standardsStatistical programmingPhase III studiesFSP model experienceOncology knowledgeRegulatory interactions

Required

Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, or a related field
7+ years of experience in statistical programming within the pharmaceutical or CRO environment
Require Immunology or Immunotherapy TA
Strong experience supporting Phase III studies and BLA submissions
Advanced proficiency in SAS programming, including macro development
Solid understanding of CDISC standards (SDTM, ADaM)

Preferred

Experience working in an FSP or sponsor-dedicated model is highly preferred
Oncology is a plus
Experience working directly with sponsor teams
Exposure to regulatory interactions and submission timelines

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
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