Office of Biostatistics
E392789
The Office of Biostatistics is a specialized FDA unit that provides statistical expertise and evaluation for drug development and regulatory decision-making.
All labels observed (2)
| Label | Occurrences |
|---|---|
| Office of Biostatistics canonical | 1 |
| Office of Biostatistics and Pharmacovigilance | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T3849415 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: Office of Biostatistics Context triple: [Center for Drug Evaluation and Research, oversees, Office of Biostatistics]
-
A.
Department of Biostatistics
The Department of Biostatistics at the Harvard T.H. Chan School of Public Health is a leading academic center for developing and applying statistical methods to advance biomedical, public health, and quantitative science research.
-
B.
Center for Biostatistics in AIDS Research
The Center for Biostatistics in AIDS Research is a Harvard-based research center that develops and applies advanced statistical methods to improve the design, analysis, and interpretation of HIV/AIDS clinical and epidemiological studies.
-
C.
Department of Statistics
The Department of Statistics at the University of Warwick is a leading academic department specializing in statistical theory, methodology, and applications, known for its strong research output and high-quality teaching.
-
D.
Department of Statistics
The Department of Statistics is an academic unit at Cairo University's Faculty of Commerce that specializes in teaching and research in statistical theory and its applications in business and economics.
-
E.
Department of Statistics
The Department of Statistics at Presidency College, Kolkata is an academic unit specializing in teaching and research in statistical theory and its applications.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: Office of Biostatistics Target entity description: The Office of Biostatistics is a specialized FDA unit that provides statistical expertise and evaluation for drug development and regulatory decision-making.
-
A.
Department of Biostatistics
The Department of Biostatistics at the Harvard T.H. Chan School of Public Health is a leading academic center for developing and applying statistical methods to advance biomedical, public health, and quantitative science research.
-
B.
Center for Biostatistics in AIDS Research
The Center for Biostatistics in AIDS Research is a Harvard-based research center that develops and applies advanced statistical methods to improve the design, analysis, and interpretation of HIV/AIDS clinical and epidemiological studies.
-
C.
Department of Statistics
The Department of Statistics at the University of Warwick is a leading academic department specializing in statistical theory, methodology, and applications, known for its strong research output and high-quality teaching.
-
D.
Department of Statistics
The Department of Statistics is an academic unit at Cairo University's Faculty of Commerce that specializes in teaching and research in statistical theory and its applications in business and economics.
-
E.
Department of Statistics
The Department of Statistics at Presidency College, Kolkata is an academic unit specializing in teaching and research in statistical theory and its applications.
- F. None of above. chosen
Statements (45)
| Predicate | Object |
|---|---|
| instanceOf |
FDA office
ⓘ
regulatory statistics unit ⓘ |
| collaboratesWith |
Center for Drug Evaluation and Research
ⓘ
surface form:
Office of New Drugs
Office of Surveillance and Epidemiology ⓘ Office of Translational Sciences ⓘ other FDA centers and offices ⓘ |
| country |
United States of America
ⓘ
surface form:
United States
|
| domain | human drugs ⓘ |
| employer |
biostatisticians
ⓘ
data scientists ⓘ statistical programmers ⓘ statistical reviewers ⓘ |
| field |
biostatistics
ⓘ
clinical trial statistics ⓘ pharmaceutical statistics ⓘ regulatory science ⓘ |
| governedBy |
FDA guidance documents
ⓘ
U.S. federal regulations ⓘ |
| hasRole |
collaborate with medical and clinical reviewers
ⓘ
conduct methodological research in biostatistics ⓘ contribute to benefit–risk assessment of drugs ⓘ develop statistical policy and guidance within CDER ⓘ evaluate statistical aspects of clinical trials ⓘ participate in advisory committee preparations ⓘ provide statistical expertise for drug development ⓘ review statistical components of drug applications ⓘ support postmarketing safety evaluations ⓘ support regulatory decision-making for drugs ⓘ |
| locatedIn | Silver Spring, Maryland ⓘ |
| mission | ensure that regulatory decisions on drugs are supported by sound statistical evidence ⓘ |
| partOf |
Center for Drug Evaluation and Research
ⓘ
Food and Drug Administration ⓘ
surface form:
U.S. Food and Drug Administration
|
| responsibleFor |
statistical input to labeling decisions
ⓘ
statistical input to regulatory guidance development ⓘ statistical review of Biologics License Applications for drugs under CDER ⓘ statistical review of Investigational New Drug submissions ⓘ statistical review of New Drug Applications ⓘ |
| usesMethod |
Bayesian statistical methods
ⓘ
adaptive trial design evaluation ⓘ frequentist statistical methods ⓘ longitudinal data analysis ⓘ missing data methods ⓘ multiplicity adjustment methods ⓘ survival analysis ⓘ |
| website | https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-biostatistics ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Office of Biostatistics Description of subject: The Office of Biostatistics is a specialized FDA unit that provides statistical expertise and evaluation for drug development and regulatory decision-making.
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.
this entity surface form:
Office of Biostatistics and Pharmacovigilance