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Pediatric Clinical Trial Biostatistics Support

Active

Federal

Response Deadline12/18/2026, 09:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The Pediatric Clinical Trial Biostatistics Support subcontract involves providing statistical leadership and analysis for prime contractors working on NIH/NICHD pediatric clinical and preclinical protocols. The selected provider will be responsible for developing Statistical Analysis Plans, performing interim and final analyses for FDA regulatory submissions, and offering oversight for protocol design. Key deliverables include validated datasets, analysis reports, and comprehensive SAPs. This engagement requires specialized expertise in pediatric-specific safety, efficacy, and pharmacokinetic studies in accordance with FDA regulatory standards. The opportunity is associated with NAICS code 541715 and is managed under the National Institutes of Health NICHD within the Department of Health and Human Services. Responses are due by December 18, 2026.

General Info

Biostatistics support for NIH pediatric trials, including analysis and SAPs for FDA submissions.

Agency

Department Of Health And Human Services → National Institutes Of Health Nichd

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

MD, USA

Set-Aside

NONE

Documents

This scope was carved out of 75N94026R00008.

The full solicitation package (4 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Best Pharmaceuticals for Children Act Data Coordination Center

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Timeline

PostedNov 3

subcontract

Response DeadlineDec 18

Submission deadline

Response Deadline

12/18/2026, 09:00:00 PM UTCin about 1 month

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Nichd

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health Nichd

Office AddressN/A

ContactsNo contact information available

Full Description

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Performs statistical leadership and analysis for prime contractors on NIH/NICHD pediatric clinical and preclinical protocols. Develops Statistical Analysis Plans (SAPs), performs interim and final analyses for FDA regulatory submissions, and provides oversight for protocol design. Requires expertise in pediatric-specific pharmacokinetic (PK), efficacy, and safety studies per FDA regulatory standards. Delivers SAPs, analysis reports, and validated datasets.

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